Compounding: Inspections, Recalls, and other Actions

Find Compounding: Inspections, Recalls, and other Actions from before 2019 in the FDA Archive

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 Active Ingredient Suppliers 

A1Rx LLC (dba Rx Unlimited Pharmacy), North Hills, CA - 503A Facility

• FMD-145 Letter Issued 03/13/2024
• Untitled Letter 4/27/2023
• 483 Issued 10/21/2022 (PDF - 885KB)

ABC Pharmacy, Inc., Encino, CA - 503A Facility

• FMD-145 Letter Issued 07/06/2020 (PDF - 63KB)
• Referral Letter to the California State Board of Pharmacy Issued 07/06/2020 (PDF - 80KB)
• 483 Issued 12/20/2019 (PDF - 254KB)

Abilene Nuclear LLC, (dba National Central Pharmacy), Abilene, TX - 503A Facility - Ceased Compounding Operations

• FMD-145 Letter Issued 01/25/2022
• Untitled Letter Issued 10/22/2020 (PDF - 818KB)
• 483 Issued 11/07/2019 (PDF - 928KB)

Absolute Pharmacy, LLC, Lutz, FL - 503A Facility - De-registered as an Outsourcing Facility

• Warning Letter Close Out Issued 07/14/2021
• FMD-145 Issued 07/14/2021

Absolute Veterinary Compounding Pharmacy, Weatherford, TX - 503A Facility

• FMD-145 Letter Issued 02/01/2021 (PDF - 177KB)

AcariaHealth Pharmacy, Inc., Falls Chuch, VA - 503A Facility - Ceased Compounding Operations

• Referral Letter to the Virginia State Board of Pharmacy dated 01/29/2020 (PDF - 113KB)
• FMD-145 Letter Issued 01/29/2020 (PDF - 121KB)

Accurate Rx Pharmacy Consulting, LLC (dba Accurate Rx Pharmacy), Columbia, MO - 503A Facility

• FMD-145 Letter Issued 06/16/2022
• Referral Letter to the Missouri Board of Pharmacy dated 06/16/2022 (PDF - 259KB)
• 483 Issued 07/15/2021 (PDF - 1.01MB)
• Warning Letter (09/02/2020)

A Chem Rx, LLC, (dba Cortez Drugs), Brooksville, FL - 503A Facility

• FMD-145 Letter Issued 06/16/2020 (PDF - 184KB)
• 483 Issued 02/07/2020 (PDF - 266KB)

ACRX Specialty Pharmacy Inc., Las Vegas, NV - 503A Facility

• FMD-145 Letter Issued 07/22/2022
• Warning Letter Close Out Issued 07/13/2022
• Referral Letter to the Nevada State Board of Pharmacy dated 07/13/2022 (PDF - 364KB)
• FMD-145 Letter Issued 07/13/2022
• 483 Issued 07/23/2021 (PDF - 1.33MB)
• Warning Letter (07/24/2020)
• 483 Issued 03/20/2019 (PDF - 1.64MB)

Advanced Compounding Solutions, (see New England Life Care, Inc.), Woburn, MA - 503A Facility

Advanced Nutriceuticals, LLC, Indianapolis, IN - 503A Facility

• Warning Letter (11/10/2021)
• 483 Issued 10/29/2020 (PDF - 3.61MB)

Age Management, Santa Barbara, CA - 503A Facility

• Warning Letter (04/18/2022)
• 483 Issued 04/12/2021 (PDF - 1.25MB)

Algunas, Inc. (dba Woodland Hills Compounding Pharmacy), Woodland Hills, CA - 503A Facility

• FMD-145 Letter Issued 03/25/2020
• State Referral Letter Issued 03/25/2020
• Warning Letter Closeout Issued 03/24/2020

Allegheny Health Network Home Infusion, LLC, Sharpsburg, PA - 503A Facility

• FMD-145 Letter Issued 04/30/2020
• State Referral Letter Issued 4/30/2020

American Specialty Pharmacy, Inc., (dba ASP Cares), San Antonio, TX - 503A Facility - De-registered as an Outsourcing Facility

• Warning Letter (04/05/2021)

Amex Pharmacy, (see Pacifico National Inc.), Melbourne, FL - 503A Facility

Anazaohealth Corporation, Las Vegas, NV - 503B Facility

• 483 Issued 07/29/2022 (PDF - 853KB)
• Warning Letter (08/18/2021)
• 483 Issued 09/19/2019 (PDF - 501KB)

Anchor Drugs Pharmacy, (see Jajco, Inc.), South San Francisco, CA - 503A Facility

Anderson Compounding Pharmacy, Inc. (dba Anderson Compounding Pharmacy), Bristol, TN - 503A Facility

• State Handoff Letter Issued 02/17/2022
• FMD-145 Letter Issued 02/17/2022
• Warning Letter Closeout Issued 02/17/2022
• Warning Letter (01/13/2020)
• 483 Issued 04/05/2019 (PDF - 1.09MB)

Annovex Pharma, Inc., Lorton, VA - 503B Facility

• 483 Issued 09/06/2024 (PDF - 1KB)

Apex Pharmacy, LLC, Beckley, WV - 503A Facility

• State Referral Letter Issued 11/16/2020
• FMD-145 Letter Issued 11/16/2020
• Untitled Letter Issued 07/28/2020 (PDF - 164KB)
• 483 Issued 11/07/2019 (PDF - 250KB)

Apollo Care LLC, Columbia, MO - 503B Facility

• 483 Issued 04/05/2023 (PDF - 2 MB)
• 483 Issued 09/8/2021 (PDF - 2 MB)
• Warning Letter (03/20/2019)

APS Pharmacy, (see Drug Depot, Inc.), Palm Harbor, FL - 503A Facility

ARJ Infusion Services, Inc., Lenexa, KS - 503A Facility

• FMD-145 Letter Issued 03/06/2019 (PDF - 88 KB)
• Warning Letter Closeout (03/06/2019)
• State Handoff Letter Issued 03/06/2019 (PDF - 73 KB)

Ark Pharmacy, PC (dba Regency Medical Pharmacy), Newbury Park, CA - 503A Facility

• FMD-145 Letter Issued 07/25/2022
• State Referral Letter Issued 07/25/2022
• 483 Issued 2/24/2022 (PDF - 271 KB)

Arnold Professional Pharmacy, Arnold, MD - 503A Facility

• Warning Letter Closeout Issued 12/27/2022
• State Referral Letter Issued 12/27/2022
• FMD-145 Letter Issued 12/27/2022
• 483 Issued 03/18/2022 (PDF - 713KB)
• Untitled Letter Issued 12/12/2019 (PDF - 273KB)

ASP Cares, (see American Specialty Pharmacy, Inc.), San Antonio, TX - 503A Facility - De-registered as an Outsourcing Facility

Aspirar Pharmacy, LLC, Cary, NC - 503A Facility

• State Handoff Letter Issued 08/19/2019 (PDF - 65KB)
• FMD-145 Letter Issued 08/19/2019 (PDF - 63KB)

Assurance Infusion, (see Nanobots Healthcare, LLC), Houston, TX - 503A Facility

Asteria Health, (see FH Investments Inc.), Birmingham, AL - 503B Facility

Athena Pharmacy (see Paradigm Healthcare Solutions, LLC), Mount Juliet, TN - 503A Facility

Athenex Pharma Solutions, LLC, Clarence, NY - 503B Facility - Out of business 

• 483 Issued 09/16/2022 (PDF - 503KB)
• FMD-145 Letter Issued 08/10/2021
• 483 Issued 08/28/2019 (PDF - 334KB)
• FDA Statement: FDA Statement on Court Ruling Related to Compounded Bulk Drug Substances and the Agency’s Ongoing Efforts to Implement its Compounding Authorities (08/06/2019)
• Firm Press Release: Athenex Provides an Update Regarding the Vasopressin Case (08/02/2019)
• Untitled Letter Issued 02/13/2019 (PDF - 161KB)

Atlas Pharmaceuticals, LLC, Phoenix, AZ - 503B Facility

• FMD-145 Letter Issued 05/03/2022
• 483 Issued 06/11/2021 (PDF - 860KB
• 483 Issued 05/21/2021

Auro Pharmacies, Inc., La Habra, CA - 503A Facility - Out of business

• FMD-145 Letter Issued 04/11/2023
• Referral Letter to the California State Board of Pharmacy Issued 04/06/2023 (PDF - 311KB)
• 483 Issued 08/12/2022 (PDF - 344KB)
• Warning Letter (06/03/2020)
• 483 Issued 10/18/2019 (PDF - 1.93MB)

Avella of Deer Valley, Inc. (dba Avella Specialty Pharmacy), Phoenix, AZ - 503A Facility - De-registered as an Outsourcing Facility

• Untitled Letter Issued 03/31/2021 (PDF - 171KB)

Avenue Pharmacy, Inc., (dba Pathway Pharmacy), Ocala, FL - 503A Facility

• 483 Issued 10/04/2024 (PDF - 695 KB)
• 483 Issued 12/06/2019 (PDF - 499 KB)

Axia Pharmaceuticals, (see Fusion IV Pharmaceuticals Inc.), Los Angeles, CA - 503A Facility

Banner Pharmacy Services, LLC, Chandler, AZ - 503A Facility - De-registered as an Outsourcing Facility

• FMD-145 Letter Issued 04/09/2020 (PDF - 63KB)
• Referral Letter to the Arizona State Board of Pharmacy Issued 04/09/2020 (PDF - 83KB)
• 483 Issued 10/08/2019 (PDF - 1.15MB)

Barclay Luke & Pillai Specialty Pharmacy PLLC (dba Meta Pharmacy Services), Las Vegas, NV - 503A Facility

• State Referral Letter Issued 03/15/2024 (PDF - 310KB)
• Warning Letter Closeout Issued 03/15/2024 (PDF - 173KB)
• FMD-145 Letter Issued 03/15/2024
• Untitled Letter Issued 09/14/2023 (PDF - 372KB)
• Amended 483 Issued 12/9/2022 (PDF - 1.47MB)
• 483 Issued 12/09/2022 (PDF - 1.6MB)

Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL - 503B Facility

• FMD-145 Letter Issued 09/15/2023
• 483 Issued 06/02/2023 (PDF - 194 KB)
• FMD-145 Letter Issued 04/04/2022
• Untitled Letter Issued 09/13/2021 (PDF - 2.09MB)
• 483 Issued 12/10/2019 (PDF - 951KB)

Beacon Prescriptions (see DCA Inc.), Southington, CT - 503A Facility

Bedford Pharmacy, Inc. (dba Mytilini Enterprises LLC), Bedford, NH - 503A Facility

• State Referral Letter Issued 01/11/2021
• FMD-145 Letter Issued 01/11/2021
• Warning Letter Closeout Issued 01/11/2021
• Untitled Letter Issued 10/4/2019 (PDF-100KB)

Belcher Pharmaceuticals LLC., Largo, FL - 503B Facility

• 483 Issued 08/16/2024 (PDF - 1.06MB)

Bella Pharmaceuticals, Inc., Glenview, IL - 503A Facility - Ceased Compounding Operations

• FMD-145 Letter Issued 08/03/2020
• Warning Letter (02/11/2019)

Belmar Select Outsourcing, (see BSO, LLC), Lakewood, CO - 503B Facility

Best Value Drug, (see Farmville Discount Drug, Inc.), Farmville, NC - 503A Facility

Be Well Natural Medicine, Mill Valley, CA - 503A Facility

• State Referral Letter Issued 08/15/2023
• FMD-145 Letter Issued 08/15/2023
• 483 Issued 05/20/2022 (PDF - 703KB)

Bhaumik Diversified LLC dba Texas Star Pharmacy, Dallas, TX - 503A Facility

• State Referral Letter Issued 01/17/2023
• FMD-145 Letter Issued 01/17/2023
• 483 issued 11/03/2021 (PDF - 1.5MB)

Bioscrip Infusion Services, (see HomeChoice Partners, Inc.), Augusta, GA - 503A Facility

Bioscrip Infusion Services, (see HomeChoice Partners, Inc.), Chesterfield, MO - 503A Facility

Bioscrip Infusion Services, (see InfuScience, Inc.), Chantilly, VA - 503A Facility

Blount Discount Pharmacy, Inc., Alcoa, TN - 503A Facility

• State Handoff Letter Issued 12/17/2021
• FMD-145 Letter Issued 12/17/2021
• Untitled Letter Issued 06/17/2021 (PDF - 1MB)
• 483 Issued 02/13/2020 (PDF - 1.55MB)

BMD Skincare, Inc., Canoga Park, CA - 503A Facility - Out of business

• 483 Issued 03/05/2019 (PDF - 15.6MB)

Bond Pharmacy, Inc. (dba Advanced Infusion Solutions), Dallas, TX - 503A Facility

• State Referral Letter Issued 6/23/2023
• FMD-145 Issued 6/23/2023
• 483 Issued 01/30/2023 (PDF - 491KB)

Boothwyn Pharmacy LLC, Kennett Square, PA - 503A Facility

• Amended 483 Issued 9/12/2023 (PDF - 931KB)
• 483 Issued 09/08/2021 (PDF - 10.7MB)

Botrosons Pharmaceutical Inc., (dba Tower Pharmacy and Compounding), Mission Viejo, CA - 503A Facility

• State Referral Letter Issued 03/08/2022
• FMD-145 Letter Issued 03/08/2022
• Untitled Letter Issued 10/20/2021 (PDF - 201KB)
• 483 Issued 09/19/2019 (PDF - 1.05MB)

BPI Labs, LLC, Largo, FL - 503B Facility

• FMD-145 Letter Issued 09/01/2021
• 483 Issued 04/30/2021 (PDF - 2.17MB)

brandMD Skin Care, (see TSDR Pharmacy, Inc.), Chatsworth, CA - 503A Facility

Brookfield Pharmacy, Brookfield, CT - 503A Facility

• State Referral Letter Issued 05/22/2019
• FMD-145 Letter Issued 05/22/2019

Brookfield Medical/Surgical Supply, Inc., Brookfield, CT - 503B Facility

• Untitled Letter Issued 09/27/2024 (PDF - 212 KB)
• 483 Issued 05/10/2024 (PDF - 991KB)
• FMD-145 Letter Issued 02/06/2023 
• 483 Issued 04/04/2022 (PDF - 4.6MB)

BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility

• 483 Issued 07/03/2024 (PDF - 1.37MB)
• FMD-145 Letter Issued 09/15/2021
• 483 Issued 03/11/2021 (PDF - 1.1MB)
• FMD-145 Letter Issued 6/22/2020 (PFD-60KB)
• 483 Issued 09/20/2019 (PDF - 265KB)
• Untitled Letter Issued 01/10/2019 (PDF - 698KB)

Buderer Drug Company Inc. Avon, OH - 503A Facility

• Referral Letter to the Ohio State Board of Pharmacy Issued 10/29/2019 (PDF - 126KB)
• FMD-145 Letter Issued 10/21/2019 (PDF - 106KB)
• 483 Response Letter Dated 03/15/2019 (PDF - 679KB)
• 483 Issued 02/14/2019 (PDF - 268KB)

Buderer Drug Company Inc. Perrysburg, OH - 503A Facility

• Referral Letter to the Ohio State Board of Pharmacy Issued 05/01/2019 (PDF - 98KB)
• Warning Letter CloseOut (05/01/2019)
• FMD-145 Letter Issued 05/01/2019 (PDF - 105KB)

Buffalo Pharmacies, Inc. dba Swan Prescription Center, East Amherst, NY - 503A Facility

• State Referral Letter Issued 9/16/2019 (PDF - 127KB)
• FMD-145 Letter Issued 9/16/2019 (PDF - 105KB)

Burt's Pharmacy LLC, Newbury Park, CA - 503A Facility

• FMD-145 Letter Issued 05/23/2023
• Referral Letter to the California State Board of Pharmacy Issued 05/23/2023 (PDF - 301KB)
• 483 Issued 10/07/2022 (PDF - 5.63MB)

California Pharmacy and Compounding Center, Newport Beach, CA - 503A Facility - De-registered as an Outsourcing Facility

• State Referral Letter Issued 02/24/2020
• FMD-145 Letter Issued 02/24/2020

California Specialty Pharmacy, Inc., Whittier, CA - 503A Facility

• FMD-145 Letter Issued 11/16/2020
• Untitled Letter Issued 05/20/2020 (PDF - 204KB)
• 483 Issued 05/17/2019 (PDF - 397KB)

Cape Drugs, (see Valgene Incorporated), Annapolis, MD - 503A Facility

CareFirst Specialty Pharmacy LLC, Mount Laurel, NJ - 503A Facility

• FMD-145 Letter Issued 03/31/2023
• State Referral Letter Issued 3/31/2023 (PDF - 263 KB)
• 483 Issued 11/30/2022 (PDF - 285 KB)

Carlton’s Dunwoody Pharmacy Corp, (dba Concord, Inc.), Dunwoody, GA - 503A Facility

• Referral Letter to the Georgia State Board of Pharmacy Issued 11/18/2019 (PDF - 68 KB)
• FMD-145 Letter Issued 11/18/2019 (PDF - 66 KB)
• 483 Issued 04/12/2019 (PDF - 79 KB)

Carolina Infusion, Ridgeland, SC - 503A Facility

• Warning Letter (05/22/2023)
• 483 Issued 08/12/2022 (PDF - 918KB)

Cascade Specialty Pharmacy, (see Poulsbo Compounding Pharmacy, LLC), Poulsbo, WA - 503A Facility

Central Admixture Pharmacy Services, Inc., Phoenix, AZ - 503B Facility

• Warning Letter Issued 03/25/2024
• 483 Issued 7/31/2023
• FMD-145 Letter Issued 1/18/2023
• Warning Letter Response 01/11/2023
• 483 Issued 02/25/2022 (PDF - 2 MB) 
• FMD-145 Letter Issued 06/03/2020 (PDF - 57 KB)

Central Admixture Pharmacy Services, Inc. (CAPS), New Orleans, LA

• Untitled Letter Issued 03/25/2022
• 483 issued on 05/24/2021

Central Admixture Pharmacy Services, Inc. (CAPS), San Diego, CA - 503B Facility - De-registered as an Outsourcing Facility

• Warning Letter Issued 07/10/2024
• 483 Issued 08/25/2023 (PDF - 7 MB)
• FMD-145 Letter Issued 05/27/2020 (PDF - 72 KB)

Central Admixture Pharmacy Services, Inc. (CAPS), Harahan, LA - 503A Facility

• Referral Letter to the Louisiana Board of Pharmacy Issued 11/03/2022 (PDF - 190 KB)
• FMD-145 Letter Issued 11/03/2022
• Untitled Letter Issued 03/25/2022 (PDF - 754KB)
• 483 Issued 05/24/2021 (PDF - 731KB)

Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA - 503B Facility

• Warning Letter Issued 03/29/2024
• 483 Issued 03/30/2023 (PDF - 1.53 MB)
• FMD-145 Letter Issued 06/17/2020 (PDF - 74KB)
• Warning Letter Closeout Issued 06/17/2020

Central Admixture Pharmacy Services, Inc. (CAPS), Cranberry Township, PA - 503A Facility

• State Referral Letter Issued 10/11/2022
• FMD-145 Issued 10/11/2022
• 483 Issued 05/04/2022 (PDF - 6 MB)

Central Illinois Compounding, Inc. (dba Preckshot Professional Pharmacy), Peoria Heights, IL - 503A Facility

• Warning Letter Response 01/11/2023
• State Referral Letter Issued 02/11/2021
• FMD-145 Letter Issued 02/11/2021

CFP Acquisitions, Inc. dba The Apothecary Shoppe, Tulsa, OK

• State Referral Letter Issued 3/24/2023
• Warning Letter Closeout Issued 3/7/2023
• FMD-145 Letter Issued 03/07/2023
• 483 Issued 01/18/2022 (PDF - 706KB)

Chastains, Inc., (dba Owl Tri State Pharmacy), Clarkston, WA - 503A Facility

• FMD-145 Letter Issued 01/21/2022
• State Referral Letter Issued 01/21/2022
• 483 Issued 08/27/2021 (PDF - 345KB)

Chen Shwezin, Inc., (dba Park Compounding Pharmacy), Westlake Village, CA - 503A Facility

• FMD-145 Letter Issued 07/20/2020 (PDF - 62KB)
• Warning Letter Closeout Issued 07/20/2020
• Referral Letter to the California State Board of Pharmacy Issued 07/20/2020 (PDF - 58KB)

Civic Center Pharmacy, Scottsdale, AZ - 503A Facility

• State Referral Letter Issued 04/02/2019
• FMD-145 Letter Issued 04/02/2019
• Warning Letter Closeout 04/02/2019

Claremore Compounding Center, Inc., Claremore, OK - 503A Facility

• State Handoff Letter Issued 04/28/2021
• FMD-145 Letter Issued 04/28/2021
• Untitled Letter Issued 08/21/2020 (PDF - 1.63MB)
• 483 Issued 01/24/2020 (PDF - 3.76MB)

CMC Enterprise Pharmacy, Charlotte, NC - 503A Facility - Out of business

• FMD-145 Letter Issued 07/17/2020
• FMD-145 Letter Issued 07/17/2020 (PDF - 190KB)
• Warning Letter (06/04/2020)

Coastal Meds, LLC., Biloxi, MS - 503A Facility

• FMD-145 Letter Issued 11/05/2019 (PDF - 67KB)
• Referral Letter to the Mississippi State Board of Pharmacy Issued 11/05/2019 – Shutdown Letter (PDF - 97KB)

Coast Quality Pharmacy, LLC, Tampa, FL - 503A Facility

• FMD-145 Letter Issued 06/29/2022
• 483 Issued 05/09/2019 (PDF - 1.16MB)

College Pharmacy Incorporated, Colorado Springs, CO - 503A Facility

• State Handoff Letter Issued 7/19/2022
• Warning Letter Closeout Issued 7/19/2022
• FMD-145 Letter Issued 07/19/2022

Colonia Care Pharmacy, Colonia, NJ - 503A Facility

• State Action Letter Issued 7/13/2023 (PDF - 744 KB)
• 483 Response Dated 08/17/2021 (PDF - 718 KB)
• 483 Issued 07/26/2021 (PDF - 736 KB)
• 483 Issued 04/29/2019 (PDF - 601 KB)

Columbia River Pharmacy, LLC, (dba Malley's Compounding Pharmacy), Richland, WA - 503A Facility

• State Referral Letter Issued 07/19/2021
• FMD-145 Letter Issued 07/19/2021
• 483 Issued 08/16/2019 (PDF - 281KB)

Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL - 503A Facility - De-registered as an Outsourcing Facility

• 483 Issued 01/23/2019 (PDF - 914KB)

Compound Care Pharmacy, Louisville, KY - 503A Facility

• State Referral Letter Issued 06/04/2020
• FMD-145 Letter Issued 06/04/2020 (PDF - 106KB)
• 483 Issued 05/16/2019 (PDF - 169KB)

Compound Preferred LLC, Idaho Falls, ID - 503B Facility

• 483 Issued 12/17/2021 (PDF - 2.57MB)
• 483 Issued 08/01/2019

Compounded Solutions in Pharmacy LLC, Monroe CT - 503A Facility

• 483 Issued 07/27/2021 (PDF - 966KB)
• 483 Issued 08/29/2019

Compoundia Pharmacy, Corpus Christi, TX - 503A Facility

• State Handoff Letter Issued 05/24/2023        
• FMD-145 Issued 05/24/2023

Concord, Inc. (see Carlton's Dunwoody Pharmacy), Dunwoody, GA - 503A Facility

Conrad-Marr Drug, (see McAlister Drug Corporation), Yukon, OK - 503A Facility

Conversio Health, (see Integrated Health Concepts Inc.), San Luis Obispo, CA - 503A Facility

Coram Healthcare Corp. of Indiana, Crown Point, IN - 503A Facility - Out of business

• FMD-145 Letter Issued 03/07/2019 (PDF - 89KB)

Cortez Drugs, (see A Chem Rx, LLC), Brooksville, FL - 503A Facility

Crawford's Professional Drugs, Inc., (dba Diket's Professional Drugs, Inc.), Laurel, MS - 503A Facility

• Referral Letter to the Mississippi Board of Pharmacy Issued 06/27/2019 (PDF - 59KB)
• FMD-145 Letter Issued 06/27/2019 (PDF - 64KB)

CRC Pharmacy, Roswell, GA - 503A Facility

• Referral Letter to the Georgia State Board of Pharmacy Issued 02/15/2017 (PDF - 195KB)

Crosby’s Drugs Inc., Columbus, OH - 503A Facility

• 483 Issued 09/30/2021 (PDF - 1.36MB)

Crowder's Institutional Pharmacy LLC., dba Crowder's Long-Term Care Pharmacy, Bedford, IN - 503A Facility

• Referral Letter to the Indiana State Board of Pharmacy Issued 10/02/2019 (PDF - 579KB)
• FMD-145 Letter Issued 10/02/2019 (PDF - 513KB)

CSRX Inc., (dba Rushmore Compounding Pharmacy), Rapid City, SD - 503A Facility

• FMD-145 Letter Issued 02/19/2019 (PDF -  66KB)

Curexa, (see EHT Pharmacy LLC), Egg Harbor Township, NJ - 503A Facility

Customceutical Compounding, LLC, Phoenix, AZ - 503A Facility

• Warning Letter (08/25/2020)
• 483 Issued 03/08/2019 (PDF - 957KB)

Custom Compounding Center, Little Rock, AR - 503A Facility

• FMD-145 Letter Issued 10/28/2020 (PDF - 306KB)
• Warning Letter Close Out Issued 10/28/2020
• Referral Letter to the Arkansas State Board of Pharmacy Issued 10/28/2020 (PDF - 435KB)
• 483 Issued 06/04/2019 (PDF - 196KB)

Custom RX LLC (dba Custom Rx Pharmacy and Wellness Concepts), Wichita, KS - 503A Facility

• State Handoff Letter Issued 01/20/2022
• FMD-145 Letter Issued 01/20/2022

D&D Pharma, LLC (dba MedScript Compounding Pharmacy), Noblesville, IN - 503A Facility

• State Referral Letter 03/05/2020
• FMD-145 Letter Issued 03/05/2020 (PDF - 116KB)
• 483 Issued 07/17/2019 (PDF - 458KB)

Davis City Pharmacy, Inc., Weatherford, TX

• Referral Letter to the Texas State Board of Pharmacy Issued 11/30/2022 (PDF - 287KB)
• FMD-145 Issued 11/30/2022
• Untitled Letter Issued 08/05/2022 (PDF - 157KB)
• 483 Issued 02/18/2022 (PDF - 883KB)

DCA Inc. (dba Beacon Prescriptions), Southington, CT - 503A Facility

• State Referral Letter 09/22/2021
• FMD-145 Letter 09/22/2021
• Warning Letter Closeout 09/22/2021

Delta Pharma, Inc., Ripley, MS - 503B Facility

• 483 Issued 04/12/2024 (PDF - 1.1MB)
• 483 Issued 06/02/2023 (PDF - 229KB)
• 483 Issued 05/20/2022 (PDF - 1.57MB)

Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility

• FMD-145 Letter Issued 11/20/2024
• 483 Issued 04/05/2024 (PDF - 2.18 MB)
• FMD-145 Letter Issued 03/29/2022
• 483 Issued 10/07/2021 (PDF - 8.94MB)
• FMD-145 Letter 05/26/2021
• 483 Issued 07/18/2019 (PDF - 606KB)

Designer Drugs, (see The Wellness Center Pharmacy, Inc.), Chattanooga, TN - 503A Facility

Diket's Professional Drugs, Inc., (see Crawford's Professional Drugs, Inc.), Laurel, MS - 503A Facility

Diplomat Pharmacy, Inc. (dba Diplomat Specialty Pharmacy), Flint, MI - 503A Facility

• State Referral Letter Issued 02/11/2019 (PDF - 75KB)
• FMD-145 Letter Issued 02/11/2019 (PDF - 70KB)

DNA Pharmacy Services, Inc. (dba Palm Beach Compounding), Jupiter, FL - 503A Facility - Ceased sterile compounding

• FMD 145 Letter Issued 03/05/2019

Dorneyville Pharmacy, Allentown, PA - 503A Facility

• Warning Letter Closeout Issued 06/22/2020
• FMD-145 Letter Issued 6/22/2020 (PDF-103KB)
• Untitled Letter Issued 03/04/2020 (PDF - 321KB)

Dougherty's Pharmacy, Dallas, TX - 503A Facility

• FMD-145 Letter Issued 05/18/2020 (PDF - 70KB)
• Referral Letter to the Texas State Board of Pharmacy Issued 05/18/2020 (PDF - 75KB)
• Warning Letter Closeout Issued 05/14/2020
• 483 Issued 07/01/2019 (PDF - 1.28MB)

Downing Labs, LLC, (formerly NuVision Pharmacy), Dallas, TX - 503A Facility - Out of business

• FMD-145 Letter Issued 08/06/2019 (PDF - 74KB)

Drug Crafters, L.P., Frisco, TX - 503A Facility

• State Referral Letter Issued 02/11/2019 (PDF -  67KB)

Drug Depot Inc. (dba APS Pharmacy), Palm Harbor, FL - 503A Facility

• State Referral Letter Issued 10/11/2023
• FMD-145 Issued 10/11/2023
• Warning Letter Closeout Issued 10/11/2023
• Warning Letter (03/31/2023)
• 483 Issued 06/17/2022 (PDF - 670 KB)
• FDA Press Release: FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy (04/26/2022)
• Warning Letter Closeout Issued 09/20/2019
• State Referral Letter Issued 09/20/2019
• FMD-145 Letter Issued 09/20/2019 (PDF - 63 KB)

Duren's Health Mart Pharmacy, Waynesboro, TN - 503A Facility - Ceased Compounding Operations

• Warning Letter Issued 11/01/2019

Dynalabs LLC, Saint Louis, MO - 503A Facility

• 483 Issued 09/26/2019 (PDF - 2 MB)

Eagle Pharmacy, Inc., Hoover, AL - 503B Facility

• Untitled Letter Issued 05/17/2022 (PDF - 586KB)
• 483 Issued 08/12/2021 (PDF - 985KB)

East Marietta Drug Company, Marietta, GA - 503A Facility

• FMD-145 Letter Issued 05/19/2020 (PDF - 83KB)
• Referral Letter to the Georgia State Board of Pharmacy Issued 05/19/2020 (PDF - 88KB)
• 483 Issued 08/23/2019 (PDF - 2.08MB)

Edge Pharmacy Services, LLC, Colchester, VT - 503B Facility

• DOJ Press Release District Court Enjoins Vermont Pharmacy from Distributing Drugs Not Made in Compliance with FDCA (06/13/2022)
• 483 Issued 12/01/2021 (PDF - 6.45MB)
• Untitled Letter Issued 01/22/2021
• 483 Issued 03/30/2020 (PDF - 3.6MB)

Curexa -East, LLC dba Curexa (formerly EHT Pharmacy, LLC), Egg Harbor Township, NJ - 503A Facility

• Warning Letter Issued 9/13/2023
• 483 Issued 09/09/2022 (PDF - 1.23MB)
• 483 Issued 10/09/2020 (PDF - 743KB)

Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX - 503B Facility

• 483 Issued 08/28/2024 (PDF - 2.25MB)
• 483 Issued 08/05/2022 (PDF - 20.4MB)
• Warning Letter (10/15/2021)
• 483 Issued 03/06/2020 (PDF - 1.02MB)
• Untitled Letter Issued 07/22/2019 (PDF - 106KB)
• FMD-145 Letter Issued 04/02/2019 (PDF - 51KB)

Empower Clinic Services, LLC, dba Empower Pharmacy, Houston, TX – 503A Facility

• 483 Issued 12/01/2023 (PDF - 1.78MB)

Essential Wellness Pharma, (see Kalman Health & Wellness Inc.), Peoria, IL - 503A Facility

Everwell Specialty Pharmacy, Pensacola, FL (see Pensacola Apothecary Inc.) - 503A Facility

Exela Pharma Sciences, LLC, Lenoir, NC - 503B Facility

• Untitled Letter Issued 12/02/2021
• Warning Letter Closeout Issued 04/30/2021
• Warning Letter (04/08/2021)
• 483 Issued 07/18/2019 (PDF - 1.63MB)
• FMD-145 Letter Issued 03/07/2019

Expert Compounding Pharmacy, Lake Balboa, CA - 503A Facility

• FMD-145 Letter Issued 01/06/2023
• Untitled Letter Issued 08/26/2022 (PDF - 635KB)
• 483 Issued 03/04/2022 (PDF - 1.12MB)

Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility

• 483 issued 06/28/2024 (PDF - 14 MB)
• FMD-145 Letter Issued 11/21/2022
• 483 Issued 03/24/2022 (PDF - 7 MB)
• 483 Issued 06/21/2019 (PDF - 2 MB)

Fairview Compounding Pharmacy, Minneapolis, MN - 503A Facility

• FMD-145 Letter Issued 04/29/2019 (PDF - 95 KB)
• Referral Letter to the Minnesota State Board of Pharmacy Issued 04/29/2019 (PDF - 122 KB)

Family Pharmacy of Statesville, Inc., Statesville, NC - 503A Facility

• 483 Issued 03/11/2022 (PDF - 923 KB)
• Warning Letter (11/06/2020)
• 483 Issued 02/12/2020 (PDF - 878 KB)

Far Hills Pharmacy, (see Pharmaview, Inc.), Bedminster, NJ - 503A Facility

Farmakeio Outsourcing LLC, Southlake, TX - 503B Facility

• Amended 483 Issued 6/14/2022 (PDF - 938 KB)
• Warning Letter (07/29/2021)
• 483 Issued 10/30/2019 (PDF - 2.76MB)

Farmville Discount Drug, Inc., (dba Best Value Drug), Farmville, NC - 503A Facility - Out of business

• Warning Letter (07/09/2019)

FH Investments Inc., (dba Asteria Health), Birmingham, AL - 503B Facility

• FMD-145 Letter Issued 09/10/2021

First Pharma Associates LLC (dba Riverpoint Pharmacy), Spokane, WA - 503A Facility

• State Referral Letter Issued 9/13/2021 (PDF - 140 KB)
• Warning Letter Close Out Issued 09/13/2021
• FMD-145 Letter Issued 09/13/2021
• 483 Issued 03/03/2021 (PDF - 381 KB)
• 483 Issued 06/07/2019 (PDF - 1 MB)

First Royal Care Co. LLC, (dba Red Mountain Compounding Pharmacy), Mesa, AZ - 503A Facility

• FMD-145 Letter Issued 02/13/2023
• Warning Letter Close Out (02/13/2023)
• State Referral Letter Issued 02/13/2023 (PDF - 252 KB)
• 483 Issued 09/12/2022 (PDF - 2.98 MB)
• 483 Issued 08/11/2021 (PDF - 2 MB)
• Warning Letter (09/08/2020)
• Amended 483 Issued 12/12/2019 (PDF - 1.36 MB)
• 483 Issued 06/14/2019 (PDF - 1 MB)

Flourish Integrative Pharmacy, LLC, Oklahoma City, OK - 503A Facility

• FMD-145 Letter Issued 04/15/2020 (PDF - 121 KB) 

Foothills Professional Pharmacy, Ltd., Phoenix, AZ - 503A Facility

• State Referral Letter Issued 03/16/2022
• Warning Letter Close Out Issued 03/16/2022
• FMD-145 Letter Issued 03/16/2022
• 483 Issued 10/01/2021 (PDF - 501KB)
• Warning Letter (09/09/2020)

Fresenius Kabi Compounding, LLC, Canton, MA - 503B Facility

• FMD-145 Letter Issued 08/11/2023
• 483 Issued 03/06/2023 (PDF - 494KB)
• FMD-145 Letter Issued 04/22/2020 (PDF - 88KB)

Front Door Pharmacy, LLC, (dba Pure Pharmacy), Houston, TX - 503A Facility

• 483 Issued 06/07/2021 (PDF - 306KB)
• Warning Letter (07/01/2020)
• 483 Issued 03/18/2019 (PDF - 1MB)

Front Range Laboratories, Incorporated, Loveland, CO - 503A Facility

• 483 Issued 03/20/2020 (PDF - 589KB)

Fullerton Wellness, LLC, Ontario, CA - 503A Facility - Out of business

• FDA Press Release -  FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness | FDA

Fusion IV Pharmaceuticals Inc. (dba Axia Pharmaceuticals), Los Angeles, CA - 503A Facility - De-registered as an Outsourcing Facility

• Amended 483 Issued 03/13/2020 (PDF - 3.8MB)
• 483 Issued 12/20/2019 (PDF - 3.5MB)

Geneva Woods Pharmacy, Anchorage, AK - 503A Facility

• Referral Letter to the Alaska State Board of Pharmacy dated 02/18/2020 (PDF - 98KB)
• FMD-145 Letter Issued 02/18/2020 (PDF - 79KB)
• Referral Letter to the Alaska State Board of Pharmacy dated 02/06/2020 (PDF - 72KB)
• FMD-145 Letter Issued 02/06/2020 (PDF - 62KB)
• 483 Issued 04/16/2019 (PDF - 411KB)

Gipsco Investment Corp. (dba Lee Silsby Compounding Pharmacy), Cleveland Heights, OH - 503A Facility

• State Handoff Letter Issued 01/05/2023
• FMD-145 Issued 01/05/2023
• Warning Letter Close Out Issued 01/05/2023

Good Day Pharmacy, (see Professional Pharmacy Services, Inc.), Loveland, CO - 503A Facility

Good Health Inc., (dba Premier Pharmacy Services), Baldwin Park, CA - 503A Facility

• FMD-145 Letter Issued 12/06/2019
• State Referral Letter Issued 12/06/2019

Greenpark Compounding Pharmacy, (see Prescription Labs, Inc.), Houston, TX - 503A Facility

Guardian Pharmacy Services, Dallas, TX - 503A Facility - Out of business

• FDA Press Release: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services (03/12/2019)

Hallandale Pharmacy, (see Pharmcore Inc.), Hallandale, FL - 503A Facility

Hallettsville Pharmacy, LLC, Hallettsville, TX - 503A Facility

• FMD-145 Letter Issued 03/24/2021 (PDF - 185KB)
• Referral Letter to the Texas State Board of Pharmacy Issued 03/24/2021 (PDF - 249KB)
• Untitled Letter Issued 09/29/2020 (PDF - 182KB)

Hartley Medical Center Pharmacy, Inc., Long Beach, CA - 503A Facility

• FMD-145 Letter Issued 07/06/2020

Hawaii Health Systems Corporation, (dba Kona Community Hospital Pharmacy), Kealakekua, HI - 503A Facility

• Warning Letter Close Out Issued 06/27/2022
• State Handoff Letter Issued 06/27/2022
• FMD-145 Letter Issued 06/27/2022
• Warning Letter (02/01/2021)
• 483 Issued 12/13/2019 (PDF - 1.83MB)

Hazle Compounding, LLC, Hazelton, PA, 503A Facility

• State Handoff Letter Issued 11/15/2022
• FMD-145 Issued 11/15/2022

Healthy Choice Compounding LLC, Elmsford, NY - 503A Facility

• State Referral Letter Issued 12/21/2023
• FMD-145 Letter Issued 12/21/2023
• Warning Letter Closeout Issued 12/21/2023
• Untitled Letter Issued 07/15/2022 (PDF - 350 KB)
• 483 Issued 09/24/2020 (PDF -  254 KB)

Hieber's Pharmacy, Pittsburgh, PA - 503A Facility

• State Handoff Letter Issued 05/01/2020
• Warning Letter Close Out Issued 05/01/2020
• FMD-145 Letter Issued 05/01/2020 (PDF - 84KB)
• 483 Issued 07/17/2019 (PDF - 192KB)

Hiers Enterprises, LLC, (dba Northwest Compounding Pharmacy), Roseburg, OR - 503A Facility

• FMD-145 Letter Issued 06/30/2023
• Referral Letter to the Oregon Board of Pharmacy Issued 06/30/2023 (PDF - 250KB)
• Untitled Letter Issued 09/22/2022 (PDF - 387KB)
• 483 Issued 11/10/2021 (PDF - 1.1MB)

Hikma Injectables USA Inc., Dayton, NJ - 503B Facility

• 483 Issued 06/25/2024 (PDF - 1.18MB
• FMD-145 Letter Issued 02/10/2023
• 483 Issued 06/08/2022 (PDF - 1.73MB)

Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ - 503B Facility

• 483 Issued 06/12/2024 (PDF - 755KB)
• FMD-145 Letter Issued 05/11/2023

Home Care Pharmacy of Palm Coast Inc., Palm Coast FL - 503A Facility

• Untitled Letter Issued 05/04/2020 (PDF - 485KB)

HomeChoice Partners, Inc., (dba Bioscrip Infusion Services), Augusta, GA - 503A Facility

• FMD-145 Letter Issued 04/26/2022
• State Referral Letter Issued 04/26/2022 (PDF - 162KB)
• Warning Letter Close Out Issued 04/14/2022
• 483 Issued 08/09/2021 (PDF - 905KB)
• Warning Letter (04/09/2020)

HomeChoice Partners, Inc., (dba Bioscrip Infusion Services), Chesterfield, MO - 503A Facility

• State Referral Letter Issued 12/17/2019
• FMD-145 Letter Issued 12/17/2019

HomeRx, LLC, (see WellRx, LLC), Wheaton, IL - 503A Facility

Hopkinton Drug, Inc., Hopkinton, MA - 503A Facility

• State Referral Letter Issued 03/07/2022
• FMD-145 Letter Issued 03/07/2022
• Untitled Letter Issued 09/16/2021 (PDF - 273KB)
• Amended 483 Issued 11/10/2020 (PDF - 622KB)

Hospira Inc., A Pfizer Company, McPherson, KS - 503A Facility

• 483 Issued 01/17/2020 (PDF - 2.58MB)

HV Pharmacy Inc. (dba Hunt Valley PharmaLab), Cockeysville, MD - 503A Facility

• FMD-145 Letter Issued 08/23/2019 (PDF - 323KB)
• Referral Letter to the Maryland State Board of Pharmacy Issued 08/23/2019 (PDF - 87KB)

Hybrid Pharma LLC, Deerfield Beach, FL - 503B Facility

• 483 Issued 11/09/2023 (PDF - 15MB)
• FMD-145 Letter Issued 07/10/2023
• Warning Letter (06/07/2022)
• 483 Issued 09/03/2021 (PDF - 1.42MB)
• Amended 483 Issued 06/24/2019 (PDF - 1.4MB)

Ideal Specialty Apothecary Inc., (dba Ideal Pharmacy), Union, NJ - 503A Facility

• 483 Issued 11/18/2021 (PDF - 1.48MB)
• Warning Letter (06/17/2019)

ImprimisRx, LLC, Carlsbad CA - Corporate Headquarters

• Warning Letter (06/30/2022)

ImprimisRx CA Inc. (dba ImprimisRx), Irvine CA - 503A Facility - Out of business

• Warning Letter (03/26/2019)

Imprimis NJOF, LLC, Ledgewood, NJ - 503B Facility

• 483 Issued 04/03/2024 (PDF - 3.21MB)
• 483 Issued 01/29/2021 (PDF - 5.35MB)
• Warning Letter (06/07/2019)

ImprimisRx NJ, Ledgewood, NJ - 503A Facility

• Warning Letter (05/26/2023)
• 483 Issued 08/05/2022 (PDF - 1.57MB)
• 483 Issued 04/09/2019 (PDF - 305KB)

INCELL Corporation, LLC, San Antonio, TX - 503A Facility - De-registered as an Outsourcing Facility

• Warning Letter Close Out Issued 05/24/2019

InfuScience Inc., Eagan, MN - 503A Facility

• FMD-145 Letter Issued 07/01/2019 (PDF - 101KB)
• Referral Letter to the Minnesota State Board of Pharmacy Issued 07/01/2019 (PDF - 127KB)

InfuScience, Inc., (dba Bioscrip Infusion Services), Chantilly, VA - 503A Facility

• 483 Issued 10/08/2021 (PDF - 1.17MB)
• Warning Letter (12/21/2020)
• 483 Issued 07/30/2019 (PDF - 1MB)

Infusion Options, Inc., Brooklyn, NY - 503A Facility - Out of business

• Warning Letter (08/26/2021)
• Amended 483 Issued 07/08/2019 (PDF - 2.16MB)
• 483 Issued 06/25/2019 (PDF - 261KB)

Infusion Partners, LLC, Canfield, OH - 503A Facility

• State Handoff Letter Issued 01/26/2022
• Warning Letter Close Out Issued 01/26/2022
• FMD-145 Letter Issued 01/26/2022
• Referral Letter to the Ohio Board of Pharmacy Issued 03/28/2019 (PDF - 75KB)
• Warning Letter (03/20/2019)

Infusion System of SW Florida Inc. (dba Myerlee Pharmacy), Fort Myers, FL - 503A Facility

• State Referral Letter Issued 03/17/2023
• FMD-145 Letter Issued 03/17/2023
• Warning Letter Close Out Issued 03/17/2023
• 483 Issued 08/11/2022 (PDF - 447KB)
• 483 Issued 12/17/2019 (PDF - 690KB)

Infusion Treatment Center, (dba ITC Compounding), Castle Rock, CO - 503A Facility

• FMD-145 Letter Issued 12/01/2020 (PDF - 67KB)
• Referral Letter to the Colorado Board of Pharmacy Issued 11/23/2020 (PDF - 85 KB)
• Untitled Letter Issued 08/18/2020 (PDF - 158KB)
• 483 Issued 07/23/2019 (PDF - 1.6MB)

Innovative Intrathecal Solutions, Inc. (dba Innovative Compounding Pharmacy), Murrieta, CA - 503A Facility

• State Referral Letter Issued 04/04/2022
• Warning Letter Close Out Issued 04/04/2022
• FMD-145 Letter Issued 04/04/2022
• 483 Issued 10/26/2021 (PDF - 248 KB)
• 483 Issued 02/20/2020 (PDF - 983 KB)

Innovative Medicine LLC, Long Island City, NY - 503A Facility

• Warning Letter (11/17/2020)

Innoveix Pharmaceuticals, Addison, TX - 503A Facility

• Warning Letter (01/26/2022)
• 483 Issued 05/27/2021 (PDF - 981KB)
• Firm Recall Announcement: Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance (10/10/2019)
• 483 Issued 09/12/2019 (PDF - 1.18MB)

Insight Pharmacy, Havertown, PA - 503A Facility

• FMD-145 Letter Issued 10/03/2019 (PDF - 90KB)
• State Handoff Letter Issued 10/03/2019 (PDF - 90KB)

IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility

• 483 Issued 03/01/2024 (PDF - 2.58MB)
• 483 Issued 08/02/2021 (PDF - 1.12MB)
• Warning Letter (05/06/2020)

Integrated Health Concepts Inc. (dba Conversio Health), San Luis Obispo, CA - 503A Facility

• State Referral Letter Issued 01/18/2022
• FMD-145 Letter Issued 01/18/2022
• Warning Letter Close Out Issued 01/18/2022
• 483 Issued 07/23/2021 (PDF - 454KB)
• Warning Letter (09/10/2020)
• 483 Issued 09/25/2019

Intermountain Medical Center, Murray, UT - 503A Facility

• FMD-145 Letter Issued 10/25/2019 (PDF - 123KB)

Intrathecal Compounding Specialists, LLC, Scott, LA - 503A Facility

• State Referral Letter Issued 01/19/2022
• FMD-145 Letter Issued 01/19/2022
• Warning Letter Close Out Issued 01/19/2022
• 483 Issued 08/19/2021 (PDF - 1.4MB)
• Warning Letter (09/15/2020)
• 483 Issued 02/14/2019 (PDF - 417KB)

Inventive Infusion Solutions, LP, San Antonio, TX - 503A Facility

• Untitled Letter Issued 07/15/2021 (PDF - 377KB)

Isorx, Corp., Richmond, CA - 503A Facility

• FMD-145 Letter Issued 03/17/2022
• 483 Issued 09/18/2019 (PDF - 376KB)

Jajco Inc. (dba Anchor Drugs Pharmacy), South San Francisco, CA - 503A Facility

• Referral Letter to the California State Board of Pharmacy Issued 12/06/2019 (PDF - 115KB)
• FMD-145 Letter Issued 12/06/2019 (PDF - 100KB)
• Warning Letter Close Out Issued 12/06/2019

JCB Laboratories, LLC, Wichita, KS - 503A Facility - Out of business

• FMD-145 Letter Issued 09/22/2021

JD & SN Inc. (dba Moses Lake Professional Pharmacy), Moses Lake, WA - 503A Facility

• State Referral Letter Issued 8/23/2023
• FMD-145 Issued 8/23/2023
• 483 Issued 04/04/2023 (PDF - 486 KB)

Joe Wise Pharmacy, Inc., (dba Wise Pharmacy), Littleton, CO  - 503A Facility - Out of business

• Warning Letter (04/15/2021)
• 483 Issued 06/21/2019 (PDF - 542KB) 

John L. McClellan Memorial Veterans Hospital, Little Rock, AR - 503A Facility

• Amended 483 Issued 01/23/2020 (PDF - 1.72MB)

John's Pharmacy, Inc., (dba The Sullivan Pharmacy), Sullivan, IL - 503A Facility

• State Referral Letter Issued 05/26/2020
• FMD-145 Letter Issued 05/26/2020 (PDF - 118KB)
• Untitled Letter Issued 12/09/2019 (PDF - 648KB)
• 483 Issued 02/22/2019 (PDF - 384KB)

Johnson Memorial Cancer Center, Enfield, CT - 503A Facility

• State Referral Letter Issued 11/28/2022
• FMD-145 Letter Issued 11/28/2022
• Warning Letter Close Out Issued 11/28/2022
• 483 Issued 10/21/2021 (PDF - 770KB)

Jones Drug Company, Inc., (dba Reed's Compounding Pharmacy), Tucson, AZ - 503A Facility

• State Referral Letter Issued 08/13/2020
• FMD-145 Letter Issued 08/13/2020

Jubilant Draximage Radiopharmacies Inc., (dba Jubilant Radiopharma), Orlando , FL - Nuclear Pharmacy

• State Referral Letter Issued 08/13/2024 (PDF - 178KB)
• 483 Issued 03/13/2024 (PDF - 3.7MB)

Jubilant DraxImage Radiopharmacies, Inc., (dba Triad Isotopes, Inc.), Kansas City, MO - 503A Facility

• Warning Letter Close Out Issued 06/04/2020

Kalman Health & Wellness, Inc. (dba Essential Wellness Pharma), Peoria, IL - 503A Facility

• Warning Letter Close Out Issued 09/11/2019
• Referral Letter to the Illinois State Board of Pharmacy Issued 09/11/2019 (PDF - 118KB)
• FMD-145 Letter Issued 09/11/2019 (PDF - 84KB)

Kelley-Ross Compounding Pharmacy, Seattle, WA - 503A Facility

• State Referral Letter Issued 04/08/2021
• Warning Letter Close Out Issued 04/08/2021
• FMD-145 Letter Issued 04/08/2021
• 483 Issued 09/23/2020 (PDF - 754KB)

Key Compounding Pharmacy (see Puget Sound Drug Corporation), Federal Way, WA - 503A Facility

Keystone Rx LLC, Bensalem, PA - 503A Facility

• State Referral Letter Issued 03/25/2020 (PDF - 111KB)
• FMD-145 Letter Issued 03/25/2020
• 483 Issued 07/12/2019 (PDF - 310KB)

Kings Park Slope, Inc., Brooklyn, NY - 503A Facility - De-registered as an Outsourcing Facility

• Referral Letter to the New York State Board of Pharmacy Issued 11/15/2019 (PDF - 120KB)
• FMD-145 Issued 11/15/2019 (PDF - 111KB)
• Warning Letter Closeout (11/15/2019)

Kohana Pharmacy and Center for Regenerative Medicine Inc., San Luis Obispo, CA - 503A Facility

• FMD-145 Letter Issued 11/22/2019 (PDF - 69KB)
• Referral Letter to the California State Board of Pharmacy Issued 11/22/2019 (PDF - 103KB)
• 483 Issued 04/17/2019 (PDF - 406KB)

Kohll's Compounding, Omaha, NE - 503A Facility

• FMD-145 Letter Issued 07/11/2019 (PDF - 112KB)
• Referral Letter to the Nebraska State Board of Pharmacy Issued 07/11/2019 (PDF - 264KB)

Kona Community Hospital Pharmacy, (see Hawaii Health Systems Corporation), Kealakekua, HI - 503A Facility

KRS Global Biotechnology, Inc. Boca Raton, FL - 503B Facility - Out of business

• Firm Recall Announcement: KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility (09/12/2019)
• Amended 483 Issued 08/20/2019 (PDF - 2.51MB)
• FMD-145 Letter Issued 06/13/2019

Ladd Family Pharmacy LLC, Boise, ID - 503A Facility

• State Referral Letter Issued 04/09/2020
• Warning Letter Close Out Issued 04/09/2020
• FMD-145 Letter Issued 04/09/2020
• 483 Issued 07/30/2019 (PDF - 321KB)

La Vita Compounding Pharmacy, LLC, San Diego, CA - 503A Facility

• State Referral Letter Issued 09/03/2020
• Warning Letter Close Out Issued 09/03/2020
• FMD-145 Letter Issued 09/03/2020
• 483 Issued 03/11/2020 (PDF - 868KB)
• Warning Letter (02/28/2019)

LeeSar, Inc., Fort Myers, FL - 503B Facility

• Untitled Letter Issued 06/17/2022 (PDF - 7.62 MB)
• 483 Issued 10/29/2021 (PDF - 976KB)
• Warning Letter (02/18/2020)

Lee Silsby Compounding Pharmacy, (see Gipsco Investment Corp.), Cleveland Heights, OH - 503A Facility

Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA - 503A Facility

• FMD-145 Letter Issued 08/03/2021

Leiter's Health, (see Denver Solutions, LLC), Englewood, CO - 503A Facility

Liberty Drug and Surgical, Chatham, NJ - 503A Facility

• Warning Letter Close Out Issued 02/25/2019
• FMD-145 Letter Issued 02/25/2019 (PDF - 108KB)

Life Science Pharmacy, Inc., Harriman, NY - 503A Facility

• Untitled Letter Issued 12/09/2020 (PDF - 211KB)
• 483 Issued 11/20/2019 (PDF - 663KB)

Lifetime Value Pharmacy III Inc., Santa Ana, CA - 503A Facility

• State Referral Letter Issued 09/21/2021
• FMD-145 Letter Issued 09/21/2021
• Untitled Letter Issued 09/22/2020 (PDF - 130KB)
• 483 Issued 02/21/2019 (PDF - 1.9MB)

Lloyd Central Compounding Pharmacy, (see Portland Compounding Pharmacy, LLC), Portland, OR - 503A Facility

Lynn Oaks Compounding Pharmacy, Thousand Oaks, CA - 503A Facility

• State Referral Letter Issued 06/09/2023 (PDF - 317 KB)
• Warning Letter Closeout Issued 06/09/2023
• FMD-145 Letter Issued 06/09/2023
• Untitled Letter Issued 12/08/2022 (PDF - 401KB)
• 483 Issued 04/15/2022 (PDF - 1.19MB)

M Drug, LLC, (dba Northern Light Pharmacy), Bangor, ME - 503A Facility

• State Referral Letter Issued 04/01/2020 (PDF - 180KB)
• FMD-145 Letter Issued 04/01/2020 (PDF - 164KB)
• Amended 483 Issued 08/20/2019 (PDF - 819KB)

Maag Prescription Center LLC, Pocatello, ID - 503A Facility

• FMD-145 Letter Issued 09/23/2021
• Untitled Letter Issued 10/01/2020 (PDF - 182KB)
• Maag Prescription Center LLC. Pocatello, ID. Untitled Letter issued 10/01/2020

Magellan Rx Pharmacy LLC, Astoria, NY - 503A Facility

• Warning Letter Close Out Issued 06/06/2019
• FMD-145 Letter Issued 06/06/2019 (PDF - 92KB)
• State Handoff Letter Issued 06/06/2019 (PDF - 95KB)

Maimonides Medical Center-Pharmacy, Brooklyn, NY - 503A Facility

• State Referral Letter Issued 07/20/2023 (PDF - 267KB)
• FMD-145 Issued 07/20/2023
• 483 Issued 03/09/2023 (PDF - 748KB)
• 483 Issued 07/29/2019 (PDF - 2.1MB)

Maitland Labs of Central Florida, Orlando, FL - 503A Facility - Out of business

• Warning Letter (08/06/2021)
• 483 Issued 02/28/2020 (PDF - 1MB)
• 483 Issued 06/17/2019 (PDF - 1.06MB)

Malley's Compounding Pharmacy, (see Columbia River Pharmacy, LLC), Richland, WA - 503A Facility

Malanda, Inc., (dba Mandell's Clinical Pharmacy), Somerset, NJ - 503A Facility

• Warning Letter Close Out Issued 11/09/2022
• FMD-145 Letter Issued 11/09/2022
• State Referral Letter Issued 11/9/2022
• 483 Issued 06/17/2022 (PDF - 662KB)
• Warning Letter (06/09/2020)
• 483 Issued 07/25/2019 (PDF - 746KB)

Maplerose Enterprises, LLC (dba Pencol Pharmacy), Denver, CO - 503A Facility

• State Referral Letter Issued 03/10/2022
• FMD-145 Letter Issued 03/10/2022
• Warning Letter Close Out Issued 03/10/2022
• Untitled Letter Issued 08/18/2020 (PDF - 102 KB)
• Amended 483 Issued 02/26/2019 (PDF - 1.9 MB)

Mark Cuban Cost Plus Manufacturing and Compounding LLC. Dallas, TX. - 503B Facility

• 483 Issued 09/06/2024 (PDF - 1 MB)

Mark Drugs Pharmacy, (see Snyder Mark Drugs Roselle, Inc.), Roselle, IL - 503A Facility

Maryland Specialty and Compounding, LLC, (dba Professional Arts Pharmacy), Baltimore, MD - 503A Facility - Ceased sterile compounding

• Warning Letter Close Out Issued 5/29/2020 (PDF-186KB)
• State Referral Letter Issued 5/29/2020 (PDF-203KB)
• FMD-145 Letter Issued 5/29/2020
• State Referral Letter Issued 03/11/2019

MasterPharm LLC. Richmond Hill, NY - 503A Facility - Out of business

• Warning Letter (07/19/2021)
• 483 Issued 6/15/2020 (PDF - 8 MB)

Matthew 7:25 Inc, (dba Thrive Pharmacy), Jacksonville, FL - 503A Facility

• FMD-145 Letter Issued 01/27/2023
• State Handoff Letter Issued 01/23/2023
• Warning Letter Close Out Issued 01/23/2023
• Warning Letter (07/22/2021)

Mayo Clinic Pharmacy, Rochester, MN - 503A Facility

• FMD-145 Letter Issued 04/10/2019 (PDF - 104KB)
• Referral Letter to the Minnesota State Board of Pharmacy Issued 04/10/2019 (PDF - 123KB)

McAlister Drug Corporation, (dba Conrad-Marr Drug), Yukon, OK - 503A Facility

• Referral Letter to the Oklahoma State Board of Pharmacy Issued 10/2/2020 (PDF - 199KB)
• FMD-145 Letter Issued 10/01/2020
• Untitled Letter Issued 08/21/2020 (PDF - 222KB)
• 483 Issued 10/03/2019 (PDF - 1.01MB)

McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA - 503A Facility

• State Referral Letter Issued 05/29/2020
• FMD-145 Letter Issued 05/29/2020 (PDF - 60KB)
• 483 Issued 11/22/2019 (PDF - 978KB)

Medcraft LLC, Mounds, OK - 503A Facility - Out of business

• FMD-145 Letter Issued 01/30/2019 (PDF - 77 KB)

Medi-Fare Drug and Pharmaceutical Compounding, LLC, Blacksburg, SC - 503B Facility

• FMD-145 Letter Issued 10/23/2023
• 483 Issued 05/26/2023 (PDF - 506 KB)
• Untitled Letter 03/18/2019 (PDF - 2 8MB)

Medical Center Pharmacy, Inc., Cleveland, TN - 503A Facility - De-registered as an Outsourcing Facility

• 483 Issued 04/09/2020 (PDF - 2.2MB)

MedisourceRx, Los Alamitos, CA - 503B Facility

• FMD-145 Letter Issued 04/14/2023
• FMD-145 Letter Issued 06/28/2021
• 483 Issued 10/22/2020 (PDF - 1.15MB)

Medlife Pharmacy and Compounding, Inc., Irvine, CA - 503A Facility

• State Handoff Letter Issued 11/29/2021
• FMD-145 Letter Issued 11/29/2021
• Warning Letter Close Out Issued 11/29/2021
• Warning Letter (04/24/2020)

Medoz Pharmacy of Polk, Inc., Davenport, FL - 503A Facility - Ceased sterile compounding

• State Referral Letter Issued 03/30/2022
• FMD-145 Letter Issued 03/30/2022
• Warning Letter Close Out Issued 03/30/2022
• 483 Issued 08/27/2021 (PDF - 244KB)
• Warning Letter (09/25/2020)
• 483 Issued 08/09/2019 (PDF - 1.21MB)

MedScript Compounding Pharmacy, (see D&D Pharma, LLC), Noblesville, IN - 503A Facility

Med Shop Total Care, Inc., Longview, TX - 503A Facility

• State Referral Letter Issued 10/11/2023
• FMD-145 Issued 10/11/2023
• Warning Letter Closeout Issued 10/11/2023
• 483 Issued 06/08/2023 (PDF - 457 KB)
• Warning Letter (03/18/2022)
• 483 Issued 07/27/2021 (PDF - 9.94KB)

Meta Pharmacy Services, (see Barclay Luke & Pillai Specialty Pharmacy PLLC), Las Vegas, NV - 503A Facility - De-registered as an Outsourcing Facility

Metro Drugs 3rd Avenue Corp, New York, NY - 503A Facility

• State Referral Letter Issued 09/22/2021
• FMD-145 Letter Issued 09/22/2021
• Untitled Letter Issued 01/08/2021 (PDF - 658KB)
• 483 Issued 04/05/2019 (PDF - 3.92MB)

Michigan Medicine, Ann Arbor, MI - 503A Facility

• Warning Letter Close Out Issued 06/13/2019
• FMD-145 Letter Issued 06/13/2019 (PDF - 88KB)
• Referral Letter to the Michigan State Board of Pharmacy Issued 06/13/2019 (PDF - 123KB)

Millers of Wyckoff, Inc., Wyckoff, NJ - 503A Facility

• FMD-145 Letter Issued 06/17/2022
• Untitled Letter Issued 12/01/2021 (PDF - 339KB)
• 483 Issued 10/09/2020 (PDF - 620KB)
• Warning Letter CloseOut (02/26/2019)
• FMD-145 Letter Issued 02/26/2019
• State Referral Letter Issued 02/26/2019 (PDF - 218KB)

Mills Pharmacy at McCalla, McCalla, AL - 503A Facility

• State Handoff Letter Issued 06/04/2020
• FMD-145 Letter Issued 6/4/2020

Molecular PharmaGroup, LLC, New Providence, NJ - 503B Facility

• FMD-145 Letter Issued 03/18/2024

Montana Compounding Pharmacy dba Montana Compounding Pharmacy and Wellness Center, Missoula, MT - 503A Facility

• State Referral Letter Issued 02/01/2022
• Warning Letter Close Out Issued 02/01/2022
• FMD-145 Letter Issued 02/01/2022
• 483 Issued 09/22/2021(PDF -1.04MB)

Morton Drug Company (dba Morton LTC), Neenah, WI - 503A Facility

• Warning Letter Close Out Issued 06/13/2019
• FMD-145 Letter Issued 06/13/2019 (PDF - 109KB)
• Referral Letter to the Wisconsin State Board of Pharmacy Issued 06/13/2019 (PDF - 710KB)

Moses Lake Professional Pharmacy, (see JD & SN Inc.), Moses Lake, WA  - 503A Facility

MPRX Inc., dba Medical Park Pharmacy, Dallas, TX - 503A Facility - Out of business

• 483 Issued 11/22/2019 (PDF - 369KB)

MSLS LLC, (dba The Medicine Shoppe), Lees Summit, MO - 503A Facility

• State Referral Letter Issued 04/27/2023
• FMD-145 Letter Issued 04/27/2023
• 483 issued 9/28/2022 (PDF - 5.5MB)

Myerlee Pharmacy, (see Infusion System of SW Florida), Fort Myers, FL - 503A Facility

Mytilini Enterprises LLC, (see Bedford Pharmacy Inc.), Bedford, NH - 503A Facility

Nanobots Healthcare, LLC, (dba Assurance Infusion), Houston, TX - 503A Facility - Out of business

• Warning Letter (06/12/2020)
• 483 Issued 12/03/2019 (PDF - 645KB)

National Central Pharmacy, (see Abilene Nuclear LLC), Abilene, TX - 503A Facility

Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility

• 483 Issued 09/25/2024 (PDF - 1.35 MB)
• 483 Issued 02/10/2023 (PDF - 5 MB)
• Warning Letter Issued 10/21/2022
• 483 Issued 04/20/2022 (PDF - 3 MB)
• FMD-145 Letter Issued 04/13/2022
• 483 Issued 11/15/2019 (PDF - 2 MB)
• FMD-145 Letter Issued 05/17/2019

New England Compounding Center, Framingham, MA - 503A Facility

• Unlicensed Pharmacy Technician Sentenced for Working at New England Compounding Center (7/17/2019)

New England Life Care, Inc., Portland, ME - 503A Facility

• State Referral Letter Issued 10/08/2019
• FMD-145 Letter Issued 10/08/2019

New England Life Care, Inc., (dba Advanced Compounding Solutions), Woburn, MA - 503A Facility - De-registered as an Outsourcing Facility 

• Warning Letter Issued 05/16/2023
• 483 Issued 04/28/2022 (PDF - 3.08MB)
• Untitled Letter Issued 8/21/2019 (PDF - 182KB)

New England Life Care, Inc., Woburn, MA - 503A Facility

• State Referral Letter Issued 07/31/2019
• FMD-145 Letter Issued 07/31/2019

New Era Pharmacy, LLC, (see Pharmacy Acquisition Co., LLC), Portland, OR - 503A Facility

New Vitalis Pharmacy, LLC, (dba New Vitalis Pharmacy), Louisville, KY - 503A Facility

• 483 Issued 7/5/2023 (PDF - 2 MB)
• Warning Letter (05/18/2022)
• 483 Issued 08/27/2021 (PDF - 894KB)

North American Custom Laboratories, LLC (dba FarmaKeio Superior Custom Compounding), Richardson, TX – 503A Facility

• Warning Letter Issued 11/18/2022
• FDA Statement: FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding (3/30/2022)
• 483 Issued 03/10/2022 (PDF - 1.46MB)

Northern Light Pharmacy, (see M Drug, LLC), Bangor, ME - 503A Facility

Northern VA Compounders PLLC, Sterling, VA - 503A Facility

• 483 Issued 12/09/2022 (PDF - 2MB)

North Laurel Discount Drug, Inc., (dba Quinn Pharmacy), Laurel, MS - 503A Facility

• FMD-145 Letter Issued 10/15/2020 (PDF - 252KB)
• Untitled Letter Issued 06/11/2020 (PDF - 467KB)

Northwest Compounding Pharmacy, (see Hiers Enterprises, LLC), Roseburg, OR - 503A Facility

Nubratori Inc. dba Nubratori Rx, Torrance, CA - 503B Facility

• 483 Issued 07/26/2024 (PDF - 1.25MB)
• FMD-145 Letter Issued 05/06/2022
• FMD-145 Letter Issued 09/21/2021
• 483 Issued 09/26/2019 (PDF - 637KB)
• FMD-145 Letter Issued 05/15/2019 (PDF - 65KB)

Nutrishare Inc., Louisville, KY - 503A Facility

• Referral Letter to the Kentucky State Board of Pharmacy Issued 03/04/2020 (PDF - 594 KB)
• FMD-145 Letter Issued 03/04/2020 (PDF - 104KB)
• Warning Letter Close Out Issued 03/04/2020

NuVision Pharmacy, (see Downing Labs, LLC), Dallas, TX - 503A Facility

O'Brien Pharmacy, Mission, KS - 503A Facility

• State Handoff Letter Issued 12/08/2021
• FMD-145 Letter Issued 12/08/2021

Olympia Pharmacy, (see OPS International, Inc.), Orlando, FL - 503B Facility

One Way Drug, LLC, (dba Partell Specialty Pharmacy), Las Vegas, NV - 503A Facility

• State Referral Letter Issued 06/16/2020
• FMD-145 Letter Issued 6/16/2020 (PDF-61KB)
• Warning Letter Close Out Issued 06/16/2020
• 483 Issued 11/25/2019 (PDF - 351KB)
• Warning Letter (03/13/2019)

OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL - 503B Facility

• 483 Issued 05/29/2024 (PDF - 447KB)
• 483 Issued 03/02/2022 (PDF - 4.08MB)

Option Care, Wood Dale, IL - 503A Facility

• FMD-145 Letter Issued 07/01/2020 (PDF - 121KB)
• FMD-145 Letter Issued 07/01/2020 (PDF - 96KB)
• Referral Letter to the Illinois State Board of Pharmacy Issued 07/01/2020 (PDF - 110KB)
• Warning Letter Close Out Issued 07/01/2020

Option Care Enterprises, Inc., (dba Option Care), Little Rock, AR - 503A Facility

• State Referral Letter Issued 12/20/2019 (PDF - 82KB)
• FMD-145 Letter Issued 12/20/2019 (PDF - 57KB)
• 483 Issued 03/12/2019 (PDF - 354KB)

Option Care Enterprises, Columbia, MD - 503A Facility

• FMD-145 Letter Issued 4/23/2020 (PDF-232KB)
• State Referral Letter Issued 4/23/2020 (PDF-196KB)
• Warning Letter Close Out Issued 04/23/2020

Option Care Enterprises Inc. Everett WA - 503A Facility

• State Referral Letter Issued 06/30/2020
• FMD-145 Letter Issued 06/30/2020
• Warning Letter Close Out Issued 06/30/2020

Optum Compounding Services, LLC, Phoenix, AZ - 503A Facility - De-registered as an Outsourcing Facility - Ceased Compounding Operations

• FMD-145 issued 04/11/2022
• 483 Issued 08/13/2021(PDF - 2 MB)

Optum Infusion Services 308, LLC, Chandler, AZ - 503A Facility

• Warning Letter Issued 12/13/2022
• 483 issued 3/18/2022 (PDF - 1 MB)

Orsini Pharmaceutical Services, Inc., (dba Orsini Healthcare), Elk Grove Village, IL - 503A Facility

• Referral Letter to the Illinois State Board of Pharmacy Issued 10/31/2019 (PDF - 101KB)
• FMD-145 Letter Issued 10/29/2019 (PDF - 102KB)

OSRX, Inc., Missoula, MT - 503A Facility

• 483 Issued 09/23/2021 (PDF - 386KB)
• Untitled Letter Issued 10/05/2020 (PDF - 166KB)

OSRX, Inc., Missoula, MT - 503B Facility

• 483 Issued 10/25/2024 (PDF - 1.45MB)

OurPharma LLC, Fayetteville, AR - 503B Facility

• FMD-145 Letter Issued 03/14/2022
• 483 Issued 09/30/2021 (PDF - 445KB)

Overton Brooks VA Medical Center, Shreveport, LA - 503A Facility

• 483 Issued 02/12/2020 (PDF - 4.42MB)

Owl Tri State Pharmacy, (see Chastains, Inc.), Clarkston, WA - 503A Facility

Pacifica Pharmacy, Torrance, CA  - 503A Facility

• FMD-145 Letter Issued 07/08/2020 (PDF - 114KB)
• Referral Letter to the California State Board of Pharmacy Issued 07/08/2020 (PDF - 84KB)
• 483 Issued 09/09/2019 (PDF - 440KB)

Pacifico National Inc., (dba Amex Pharmacy), Melbourne, FL - 503A Facility - De-registered as an Outsourcing Facility

• Referral Letter to Florida State Board of Pharmacy Issued 03/10/2021 (PDF - 235KB)
• FMD-145 Letter Issued 03/10/2021
• FMD-145 Letter Issued 05/28/2020 (PDF - 68KB)
• Firm Press Release: Pacifico National, Inc. dba AmEx Pharmacy Issues Voluntary Nationwide Recall for all Lots of Bevacizumab (08/30/2019)
• FDA Press Release: FDA Requests Recall of Sterile Compounded Drug Products Produced by Pacifico National Inc., dba AmEx Pharmacy, Reminds Patients and Health Care Professionals to Stop Using Due to Potential Risks (08/30/2019)
• Recall Letter Issued 08/23/2019 (PDF - 720KB with Sample Letter Issued 08/02/2019 (PDF - 6.34KB)
• FDA Statement: FDA Warns Patients and Health Care Professionals not to Use Sterile Products from Pacifico National Inc., dba AmEx Pharmacy (06/28/2019)
• Amended 483 Issued 06/20/2019 (PDF - 3.11MB)

Palisades Compounding Pharmacy, Pacific Palisades, CA - 503A Facility

• FMD-145 Letter Issued 08/09/2024
• Untitled Letter (9/27/2023) (PDF- 458KB)
• 483 Issued 03/15/2023 (PDF - 484KB)

Palm Beach Compounding, (see DNA Pharmacy Services, Inc.), Jupiter, FL - 503A Facility

Paradigm Healthcare Solutions, LLC, (dba Athena Pharmacy), Mount Juliet, TN - 503A Facility

• State Handoff Letter Issued 09/13/2019 (PDF - 71KB)
• FMD-145 Letter Issued 09/13/2019 (PDF - 61KB)

Park Compounding Pharmacy, (see Chen Shwezin, Inc.), Westlake Village, CA - 503A Facility

Park Infusioncare LP (dba Preferred Homecare), Dallas, TX - 503A Facility - Out of business

• Warning Letter Close Out Issued 06/12/2019

Partell Specialty Pharmacy, (see One Way Drug, LLC), Las Vegas NV - 503A Facility

Pathway Pharmacy, (see Avenue Pharmacy, Inc.), Ocala, FL - 503A Facility

Pavilion Compounding Pharmacy, Atlanta, GA - 503A Facility

• State Referral Letter Issued 05/20/2021
• FMD-145 Letter Issued 05/20/2021
• Untitled Letter Issued 11/06/2020 (PDF - 277KB) 
• 483 Response Dated 02/27/2019 (PDF - 2.53MB)
• 483 Issued 02/08/2019 (PDF - 717KB)

Pencol Pharmacy, (see Maplerose Enterprises, LLC), Denver, CO - 503A Facility

Pensacola Apothecary Inc., (dba Everwell Specialty Pharmacy), Pensacola, FL - 503A Facility

• FMD-145 Letter Issued 04/22/2019 (PDF - 61KB)
• State Handoff Letter Issued 04/22/2019 (PDF - 54KB)
• Warning Letter CloseOut (04/22/2019)

Pentec Health, Inc., 9 Creek Parkway, Boothwyn, PA - 503A Facility - Out of business

• FMD-145 Letter Issued 04/09/2020 (PDF - 74KB)

People's Custom Rx and Clinical Care, LLC, Memphis, TN - 503A Facility

• State Referral Letter Issued 3/10/2022
• FMD-145 Letter Issued 03/10/2022
• 483 Issued 08/05/2021 (PDF - 1.05MB)
• FMD-145 Letter Issued 05/20/2020 (PDF - 199KB)
• 483 Issued 07/24/2019 (PDF - 390KB)

People's Pharmacy, Inc. #1, Austin, TX - 503A Facility

• State Referral Letter Issued 03/12/2019
• FMD-145 Letter Issued 03/12/2019

People's Pharmacy, Inc. #2, Austin, TX - 503A Facility

• Referral Letter to the Texas State Board of Pharmacy Issued 03/12/2019 (PDF - 65KB)
• FMD-145 Letter Issued 03/12/2019

Pet Pharmacy NW (formerly Health Solutions Pharmacy Center, Inc.), Corvallis, OR - 503A Facility - Ceased human drug compounding

• State Handoff Letter Issued 11/10/2022
• FMD-145 Letter Issued 11/10/2022
• Warning Letter (03/31/2020)
• 483 Issued 01/28/2019 (PDF - 1 MB)

Pharmaceutical Care Solutions dba Pharmacy Solutions, Ann Arbor, MI - 503A Facility

• Warning Letter (08/02/2021)

Pharmacy Acquisition Co., LLC, (dba NewEra Pharmacy, LLC), Portland, OR - 503A Facility

• State Referral Letter Issued 04/30/2020
• FMD-145 Letter Issued 04/30/2020 (PDF - 60KB)
• 483 Issued 11/27/2019 (PDF - 626KB)

Pharmacy Innovations, (see Southern Tier Home Infusion, Inc.), Erie, PA - 503A Facility

Pharmacy Plus, Inc. (dba Vital Care Compounder LLC), Hattiesburg, MS - 503A Facility

• Warning Letter (06/06/2023)
• 483 Issued 10/13/2022 (PDF - 1.39MB)
• 483 Issued 05/16/2019 (PDF - 786KB)

Pharmacy Resources Incorporated, Denver, CO - 503A Facility

• FMD-145 Letter Issued 03/25/2020 (PDF - 66KB)
• 483 Issued 01/29/2019 (PDF - 1.2MB)

Pharmaview, Inc., (dba Far Hills Pharmacy), Bedminster, NJ - 503A Facility

• State Referral Letter Issued 07/16/2020
• FMD-145 Letter Issued 07/16/2020 (PDF - 139KB)
• 483 Issued 11/14/2019 (PDF - 392KB)

Pharmcore Inc. (dba Hallandale Pharmacy), Hallandale, FL - 503A Facility

• State Referral Letter Issued 05/03/2022 (PDF - 231KB)
• FMD-145 Letter Issued 05/03/2022
• Warning Letter Close Out Issued 05/03/2022
• Amended 483 Issued 09/24/2021 (PDF - 420KB)
• Warning Letter (03/11/2020)

Pharm D Solutions, LLC, Houston, TX - 503A Facility - Out of business

• FDA Press Release: Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions (05/22/2019)

PharMEDium Services, LLC, Lake Forest, IL - 503A Facility

• FDA Press Release: Federal Judge Enters Consent Decree Against Compounder PharMedium Services for Violations at Multiple Facilities (5/22/2019)

PharmScript LLC, Somerset, NJ - 503A Facility

• Referral Letter to the New Jersey State Board of Pharmacy Issued 07/29/2019 (PDF - 116KB)
• FMD-145 Letter Issued 07/29/2019 (PDF - 104KB)
• Warning Letter Close Out Issued 07/29/2019

Piedmont Hospital, Inc., (dba Phcy-Corp), Atlanta, GA - 503A Facility

• Referral Letter to the Georgia State Board of Pharmacy Issued 08/14/2020 (PDF - 316KB)
• FMD-145 Letter Issued 08/14/2020 (PDF - 192KB)
• 483 Issued 02/18/2020 (PDF - 156KB)

Pine Pharmaceuticals, Tonawanda, NY - 503B Facility

• 483 Issued 9/19/2023 (PDF - 1 MB)
• 483 Issued 05/14/2021 (PDF - 1 MB)

Pine Pharmacy and Home Care Products Center, Inc., (dba Pine Pharmacy), Williamsville, NY - 503A Facility

• FMD-145 Letter Issued 04/25/2019 (PDF - 104KB)
• Warning Letter Close Out Issued 04/25/2019

Pinnacle Compounding, Missoula, MT - 503A Facility

• 483 Issued 04/25/2019 (PDF - 278KB)

Portland Compounding Pharmacy, LLC, (dba Lloyd Central Compounding Pharmacy), Portland, OR - 503A Facility

• State Referral Letter Issued 04/07/2020
• FMD-145 Letter Issued 04/07/2020 (PDF - 69KB)
• 483 Issued 11/26/2019 (PDF - 309KB)

Potter’s House Apothecary, Inc., Peoria, AZ - 503A Facility

• Referral Letter to the Arizona State Board of Pharmacy Issued 05/16/2022 (PDF - 307KB)
• FMD-145 Letter Issued 05/16/2022
• Untitled Letter Issued 09/15/2021 (PDF - 165KB)
• 483 Issued 9/16/2020 (PDF - 5 MB)

Poulsbo Compounding Pharmacy, LLC, (dba Cascade Specialty Pharmacy), Poulsbo, WA - 503A Facility

• State Referral Letter Issued 07/26/2021
• FMD-145 Letter Issued 07/26/2021
• Untitled Letter Issued 10/09/2020 (PDF - 584KB)
• 483 Issued 04/17/2019 (PDF - 710KB)

PQ Pharmacy, LLC, Brooksville, FL - 503B Facility

• FMD-145 Letter Issued 3/30/2023
• Amended 483 Issued 11/17/2022 (PDF - 1.4MB)
• 483 Issued 10/27/2022 (PDF - 1.39MB)

PrecisionMed Pharmacy, Tampa, FL - 503A Facility

• Untitled Letter Issued 6/10/2020 (PDF-255KB)
• 483 Issued 03/20/2019

Preckshot Professional Pharmacy, (see Central Illinois Compounding, Inc.), Peoria Heights, IL - 503A Facility

Preferred Homecare, (see Park Infusioncare LP), Houston, TX - 503A Facility - Out of business

Premier Pharmacy Labs, Inc., (dba Rx Nations), Weeki Wachee, FL - 503A Facility - Out of business

• FDA Press Release: Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions (09/17/2021)
• Second Amended 483 Issued 07/25/2019 (PDF - 3.63MB)
• Firm Press Release: Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance (06/18/2019)

Premier Pharmacy Services, (see Good Health Inc.), Baldwin Park, CA - 503A Facility

Prescription Alternatives, Inc., Frisco, CO - 503A Facility

• State Referral Letter Issued 08/12/2019
• FMD-145 Letter Issued 08/12/2019

Prescription Dispensing Laboratories, Inc. dba PD Labs, Cedar Park, TX - 503A Facility

• State Handoff Letter Issued 02/18/2022
• FMD-145 Letter Issued 02/18/2022
• Warning Letter Close Out Issued 02/18/2022
• Warning Letter (07/30/2019)

Prescription Labs, Inc. (dba Greenpark Compounding Pharmacy), Houston, TX - 503A Facility

• FDA Press Release: FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy (09/17/2021)
• 483 Issued 08/12/2021 (PDF -6 6MB)

Prisma Health Outsourcing Facility, Simpsonville, SC - 503B Facility

• FMD-145 Letter Issued 08/21/2023
• 483 Issued 03/03/2023 (PDF - 656 KB)

Professional Arts Pharmacy, Baltimore, MD - 503A Facility

• State Referral Letter Issued 03/11/2019
• FMD-145 Letter Issued 03/11/2019 (PDF - 130KB)
• Warning Letter Close Out (03/11/2019)

Professional Compounding Pharmacy, (see Health Solutions Pharmacy Center, Inc.), Corvallis, OR - 503A Facility - Ceased Human Drug Compounding

Professional Partners Inc./ Westcliff Compounding Pharmacy, Newport Beach, CA - 503A Facility

• Referral Letter to the California State Board of Pharmacy Issued 04/05/2017 (PDF - 357KB)
• 483 Issued 05/09/2016 (PDF - 715KB)

Professional Pharmacy Services, Inc. (dba Good Day Pharmacy), Longmont, CO - 503A Facility

• FMD-145 Letter Issued 04/14/2020 (PDF - 65KB)
• Referral Letter to the Colorado State Board of Pharmacy Issued 04/14/2020 (PDF - 83KB)
• 483 Issued 06/17/2019 (PDF - 554KB)

Promise Pharmacy, LLC, Palm Harbor, FL - 503A Facility

• Referral Letter to the Florida Board of Pharmacy Issued 07/27/2022 (PDF - 112KB)
• FMD-145 Letter Issued 07/27/2022
• Warning Letter Close Out Issued 07/27/2022
• 483 Issued 09/23/2021 (PDF - 649KB)
• Warning Letter (07/29/2019)

ProRX LLC, Exton, PA - 503B Facility

• 483 Issued 08/02/2024 (PDF - 2.78 MB)

Providence Health and Services Washington, (dba Providence Infusion Hospital Services), Tukwila, WA - 503B Facility - Out of business

• FMD-145 Letter Issued 08/16/2022
• 483 Issued 04/13/2022
• FMD-145 Letter Issued 09/10/2021
• 483 Issued 10/05/2020

Puget Sound Drug Corporation, (dba Key Compounding Pharmacy), Federal Way, WA - 503A Facility

• State Referral Letter Issued 03/31/2020
• Warning Letter Close Out Issued 03/31/2020
• FMD-145 Letter Issued 03/31/2020
• 483 Issued 06/13/2019 (PDF - 1.27MB)

Pure Pharmacy, (see Front Door Pharmacy), Houston, TX - 503A Facility

Purformance Wellness Pharmacy LLC, (dba Seven Cells), Stuart, FL - 503A Facility

• State Referral Letter Issued 06/05/2023
• FMD-145 Letter Issued 06/05/2023
• 483 Issued 12/09/2022 (PDF - 510KB)

Qualgen LLC, Edmond, OK - 503B Facility

• 483 Issued 03/19/2024 (PDF - 3MB)
• FDA Press Release: Federal Court Enters Consent Decree Against Oklahoma Drug Compounder (12/19/2022)
• 483 Issued 09/30/2022 (PDF - 1.69MB)
• 483 Issued 06/15/2021(PDF - 2.5MB)

Quinn Pharmacy, (see North Laurel Discount Drug, Inc.), Laurel, MS - 503A Facility

QuVa Pharma, Inc., Bloomsbury, NJ - 503B Facility

• Warning Letter Issued 01/26/2024
• 483 Issued 10/14/2022 (PDF - 2.54MB)
• 483 Issued 05/31/2019 (PDF - 1.69MB)

QuVa Pharma, Inc. Sugar Land, TX - 503B Facility

• FMD-145 Letter Issued 02/01/2023
• FMD-145 Letter Issued 1/24/2023 
• 483 Issued 08/18/2022 (PDF - 638KB)
• 483 Issued 04/23/2019 (PDF - 693KB)

QuVa Pharma Inc. Temple, TX - 503B Facility

• FMD-145 Issued 01/3/2023
• 483 Issued 06/16/2022 (PDF - 743KB)
• 483 Issued 03/14/2019 (PDF - 1.14MB)

RAM Pharma, Inc., Idaho Falls, ID - 503A Facility

• 483 Issued 08/01/2019 (PDF - 1 MB)

Rancho Park Compounding Pharmacy, (see Sanders Pharmaceuticals, Inc.), Los Angeles, CA - 503A Facility

Randol Mill Pharmacy, Arlington, TX - 503A Facility

• Warning Letter Close Out Issued 09/28/2022 (PDF - 174 KB)
• State Handoff Letter Issued 09/28/2022 (PDF - 158KB)
• FMD-145 Letter Issued 9/28/2022
• Warning Letter (09/17/2020)
• 483 Issued 08/06/2019 (PDF - 874KB)

Ranier’s Compounding Laboratory, Jeannette, PA - 503A Facility

• 483 Issued 02/13/2024 (PDF - 455KB)
• 483 Issued 08/16/2021 (PDF - 1 MB)
• FDA Press Release: Federal Court Enters Consent Decree Against Ranier's Rx Laboratory and Owner for Manufacturing Purportedly Sterile Drug Products in Unsanitary Conditions (02/06/2019)

RC Compounding Services, LLC, Poland, OH - 503A Facility - De-registered as an Outsourcing Facility

• Warning Letter Close Out Issued 09/12/2019
• Referral Letter to the Ohio State Board of Pharmacy Issued 09/12/2019 (PDF - 159KB)
• FMD-145 Letter Issued 09/12/2019 (PDF - 110KB)

RC Outsourcing LLC, Lowellville, OH - 503B Facility

• 483 Issued 09/27/2024 (PDF - 1.79 MB)
• 483 Issued 09/23/2022 (PDF - 1.97 MB)
• FMD-145 Letter Issued 05/22/2020 (PDF - 105 KB)
• 483 Issued 02/08/2019 (PDF - 5.39 MB)

Red Mountain Compounding Pharmacy, (see First Royal Care Co. LLC), Mesa, AZ - 503A Facility

Reed Pharmacy, Inc., Sterling, KS - 503A Facility

• Untitled Letter Issued 09/30/2019

Reed's Compounding Pharmacy, (see Jones Drug Company, Inc.), Tucson, AZ - 503A Facility

Reliant Compounded Solutions Monroe, LLC. (formerly Compounded Solutions in Pharmacy, LLC), Monroe, CT- 503A Facility

• State Referral Letter Issued 03/18/2024
• FMD-145 Letter Issued 03/18/2024
• 483 Issued 08/23/2023 (PDF - 543KB)
• 483 Issued 8/29/2019

Revive RX LLC, dba Revive RX Pharmacy, Houston, TX - 503A Facility

• Untitled Letter Issued 06/30/2023 (PDF - 256KB)
• 483 Issued 05/04/2022 (PDF - 2.5MB)
• 483 Issued 08/06/2021 (PDF - 447KB)

Right Value Drug Store, Inc., (dba Carie Boyd’s Prescription Shop), Hurst, TX - 503B Facility

• 483 Issued 06/21/2024 (PDF 1.29MB)
• 483 Issued 06/27/2022 (PDF - 2.4MB)
• Warning Letter (09/20/2021)
• 483 Issued 11/12/2019 (PDF - 1.13MB)
• Untitled Letter Issued 10/25/2019 (PDF - 347KB)

Riverpoint Pharmacy, (see First Pharma Associates LLC), Spokane, WA - 503A Facility

Rocky Mountain Pharmacy Inc, Bozeman MT - 503A Facility

• FMD-145 Letter Issued 03/18/2022
• State Handoff Letter Issued 03/16/2022
• Warning Letter Close Out Issued 03/16/2022
• Warning Letter (05/09/2019)

Roger Williams Medical Center, Providence, RI - 503A Facility

• State Handoff Letter Issued 11/29/2021
• FMD-145 Letter Issued 11/29/2021
• Untitled Letter Issued (3/18/2021) (PDF - 1 MB)
• 483 Issued 08/14/2019 (PDF - 1 MB)

Rushmore Compounding Pharmacy), (see CSRX Inc.), Rapid City, SD - 503A Facility

RX3 Pharmacy, (seeRxSouth, LLC), Chester, VA - 503A Facility

Rx Nations, (see Premier Pharmacy Labs, Inc.), Weeki Wachee, FL - 503A Facility

RXQ Compounding, LLC, Athens, OH - 503B Facility - Out of business 

• Firm Press Release: RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance (06/18/2019)
• 483 Issued 06/06/2019 (PDF - 3MB)

RxSouth, LLC, (dba RX3 Pharmacy), Chester, VA - 503A Facility

• Warning Letter Close Out Issued 06/26/2019
• FMD-145 Letter Issued 06/26/2019 (PDF - 88KB)

Rx Unlimited Pharmacy, (see A1Rx LLC), North Hills, CA - 503A Facility

Rye Beach Pharmacy, Inc., Rye, NY - 503A Facility

• FMD-145 Letter Issued 12/28/2020 (PDF - 90KB)
• Untitled Letter Issued 08/25/2020 (PDF - 151KB)

Safeway, Inc., San Jose, CA - 503A Facility

• FMD-145 Letter Issued 09/29/2020
• Referral Letter to the California State Board of Pharmacy Issued 09/29/2020 (PDF - 93KB)
• Untitled Letter Issued 03/27/2019 (PDF - 424KB)

Sagent Pharmaceuticals, Inc. (see SterRX)

Sanders Pharmaceuticals, Inc. (dba Rancho Park Compounding Pharmacy), Los Angeles, CA - 503A Facility

• Referral Letter to the California State Board of Pharmacy Issued 11/27/2020 (PDF - 63 KB)
• FMD-145 Letter Issued 11/27/2020 (PDF - 50KB)
• 483 Issued 05/07/2019 (PDF - 1.23MB)

San Diego Compounding Pharmacy, San Diego, CA - 503A Facility

• Warning Letter Close Out Issued 07/08/2019
• FMD-145 Letter Issued 07/08/2019 (PDF - 211KB)
• Referral Letter to the California State Board of Pharmacy Issued 07/08/2019 (PDF - 136KB)

San Jose Compounding Pharmacy, (see White House Pharmacy, Inc.), San Jose, CA - 503A Facility

SBH Medical LTD., Worthington, OH - 503A Facility

• State Referral Letter Issued 06/16/2020
• FMD-145 Letter Issued 06/16/2020 (PDF - 102KB)
• 483 Issued 09/30/2019 (PDF - 176KB)

SCA Pharmaceuticals, LLC, Little Rock, AR - 503B Facility

• FMD-145 Letter Issued 9/29/2023
• 483 Issued 05/17/2023 (PDF - 1 MB)
• FMD-145 Letter Issued 08/19/2021
• Warning Letter Close Out Issued 08/19/2021
• 483 Issued 11/07/2019 (PDF - 724 KB)

SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility

• 483 Response Dated 11/10/2023 (PDF - 360 KB)
• 483 Issued 10/20/2023 (PDF - 642 KB)
• FMD-145 Letter Issued 10/22/2021
• 483 Issued 11/19/2019 (PDF - 1 MB)

Sentara Enterprises, Chesapeake, VA - 503A Facility

• 483 Issued 12/16/2022 (PDF - 2 MB)

Sentara Enterprises dba Sentara Infusion Services, Charlottesville VA

• FMD-145 Letter Issued 01/26/2024
• State Referral Letter Issued 01/26/2024 (PDF - 230KB)
• 483 Issued 7/14/2023 (PDF - 505 KB)

Seven Cells, (see Purformance Wellness Pharmacy LLC), Stuart, FL

Sharp Drugs, Inc., West Hampton Beach, NY - 503A Facility Ceased Compounding Operations

• State Handoff Letter Issued 10/20/2022
• FMD-145 Letter Issued 10/20/2022
• Warning Letter (08/02/2019)

Shertech Pharmacy, LLC, Kernersville, NC - 503A Facility

• 483 Issued 07/18/2019 (PDF - 2.01MB)

Shertech Pharmacy, Easley, SC - 503A Facility

• 483 Issued 07/02/2019 (PDF - 1.16MB)

SKNV (formerly Sincerus Florida LLC), Pompano Beach FL - 503B Facility

• FMD-145 Letter Issued 09/30/2024
• 483 Issued 05/23/2024 (PDF - 227KB)
• FMD-145 Letter Issued 11/16/2020 (PDF - 209KB)

SNF Holdings, LLC, (dba Vios Compounding), Livonia, MI - 503A Facility

• Amended State Referral Letter Issued 04/09/2024 (PDF - 245KB)
• FMD-145 Letter Issued 01/29/2024
• Untitled Letter Issued 09/18/2023 (PDF - 323KB)
• 483 Issued 03/02/2023 (PDF - 780KB)

Snyder Mark Drugs Roselle, Inc. (dba Mark Drugs Pharmacy), Roselle, IL - 503A Facility

• State Referral Letter Issued 02/04/2021
• Warning Letter Close Out Issued 02/04/2021
• FMD-145 Letter Issued 02/04/2021
• 483 Issued 09/27/2019 (PDF - 412KB)

Solaris Pharmacy, Inc., Decatur, TX - 503A Facility

• State Referral Letter Issued 07/17/2020
• FMD-145 Letter Issued 07/17/2020 (PDF - 62KB)
• 483 Issued 02/26/2020 (PDF - 409KB)

South Berwick Pharmacy Seacoast Compounding, Inc., South Berwick, ME - 503A Facility

• State Referral Letter Issued 6/14/2023
• FMD-145 Letter Issued 06/14/2023
• 483 Issued 09/30/2022 (PDF - 735KB)

Southern California Compounding Pharmacy, LLC, San Diego, CA - 503A Facility

• State Referral Letter Issued 05/14/2020
• FMD-145 Letter Issued 05/14/2020 (PDF - 60KB)
• 483 Issued 08/01/2019 (PDF - 529KB)

Southern Tier Home Infusion, Inc., (dba Pharmacy Innovations), Erie, PA - 503A Facility

• Warning Letter (09/20/2023)
• 483 Issued 11/30/2022 (PDF - 1.85MB)

SSM Health Care St. Louis, (dba SSM Health St. Clare Hospital - Fenton), Fenton, MO - 503B Facility

• 483 Issued 02/08/2024 (PDF - 2.2MB)
• 483 Issued 09/28/2021 (PDF - 1.37MB)
• 483 Issued 08/28/2019 (PDF - 1.01MB)

SSM St. Clare Health Center, (see SSM Health Care St. Louis), Fenton, MO - 503A Facility

Stanley Specialty Pharmacy Compounding and Wellness Center, Charlotte, NC - 503A Facility

• State Referral Letter Issued 2/8/2022
• Warning Letter Close Out Issued 02/08/2022
• FMD-145 Letter Issued 02/08/2022
• 483 Issued 10/01/2021 (PDF - 303 KB)

STAQ Pharma, Inc., Denver, CO - 503B Facility

• FMD-145 Letter Issued 03/25/2022
• 483 Issued 09/29/2021 (PDF - 3 MB)
• FMD-145 Letter Issued 05/25/2021
• 483 Issued 09/03/2020 (PDF - 877 KB)

STAQ Pharma of Ohio, LLC, Columbus, OH – 503B Facility

• FMD-145 Letter Issued 03/20/2024
• 483 Issued 10/04/2023 (PDF - 242 KB)

Staska Pharmaceuticals, Inc., Bennet, NE - 503B Facility

• Amended 483 Issued 09/26/2024 (PDF - 1.88 MB)
• Firm Press Release: Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles | FDA

SterRx (subsidiary of Sagent Pharmaceuticals), Plattsburgh, NY - 503B Facility

• 483 Issued 6/28/2023 (PDF - 594 KB)
• Warning Letter (07/27/2022)
• 483 Issued 11/04/2021 (PDF - 6 MB)
• FMD-145 Letter Issued 07/07/2020 (PDF - 212 KB)

Stokes Healthcare Inc., (dba Epicur Pharma), Mount Laurel, NJ - 503B Facility

• 483 Issued 10/25/2023 (PDF - 14MB)
• Untitled Letter 4/27/2022 (PDF - 162KB)
• 483 Issued 10/09/2020 (PDF - 603KB)

Stonegate Pharmacy LP, Austin TX - 503A Facility

• FMD-145 Letter Issued 09/21/2020 (PDF - 121KB)
• Referral Letter to the Texas State Board of Pharmacy Issued 09/21/2020 (PDF - 210KB)
• 483 Issued 08/09/2019 (PDF - 1.48MB)
• Warning Letter Close Out Issued 04/24/2019
• FMD-145 Letter Issued 04/24/2019 (PDF - 47KB)
• Referral Letter to the Texas State Board of Pharmacy Issued 04/24/2019 (PDF - 69KB)

Stone Oak Pharmacy LP, San Antonio, TX - 503A Facility

• FMD-145 Letter Issued 03/14/2019 (PDF - 318KB)

Strive Pharmacy Texas, LLC, dba Strive Pharmacy (formerly Talon Pharmacy of Boerne) Boerne, TX - 503A Facility

• 483 Issued 09/08/2023 (PDF - 672KB)

Surgery Pharmacy Services, Inc., Chattanooga, TN - 503A Facility

• 483 Response Letter Issued 07/14/2023 (PDF - 179 KB)
• 483 Issued 07/07/2023 (PDF - 478 KB)
• Warning Letter (10/09/2020)
• 483 Issued 12/06/2019 (PDF - 755 KB)

Synthetopes, Inc., Conway, SC - 503A Facility

• 483 Issued 05/16/2019 (PDF - 1 MB)

TMC Acquisitions, LLC dba Tailor Made Compounding, LLC, Nicholasville, KY - 503A Facility

• 483 Issued 03/14/2022 (PDF - 4 MB)
• Warning Letter (04/01/2020)

Tailstorm Health, Inc., Chandler, AZ - 503B Facility

• FMD-145 Letter Issued 10/23/2023
• Untitled Letter Issued 06/17/2022 (PDF - 404 KB)
• 483 Issued 07/21/2021 (PDF - 1 MB)

Tailstorm Health, Inc., Phoenix, AZ - 503B Facility

• 483 Issued 10/10/2024 (PDF - 1.18 MB)

Talon Pharmacy of Boerne, (see Vita Pharmacy, LLC), Boerne, TX - 503A Facility

Techni Med, Inc., (dba The Compounder), Aurora, IL - 503A Facility

• Warning Letter Close Out Issued 05/05/2020
• FMD-145 Letter Issued 05/05/2020 (PDF - 101KB)
• Referral Letter to the Illinois State Board of Pharmacy Issued 05/05/2020 (PDF - 106 KB)
• 483 Issued 10/10/2019 (PDF - 553 KB)

Texas Longhorn Rx, LLC

• Warning Letter (8/30/2022)

The Compounder, (see Techni Med, Inc.), Aurora, IL  - 503A Facility

The Compounding Pharmacy, Hickory, NC - 503A Facility

• 483 Issued 09/29/2021 (PDF - 194 KB)
• Warning Letter (06/05/2020)
• 483 Issued 04/08/2019

The Compounding Pharmacy of Beverly Hills, Beverly Hills, CA - 503A Facility

• FMD-145 Letter Issued 01/13/2021 (PDF - 66 KB)
• Untitled Letter Issued 09/17/2020 (PDF - 157 KB)
• 483 Issued 08/16/2019

The Medicine Shoppe, (see MSLS LLC), Lees Summit, MO - 503A Facility

The Medicine Shoppe Pharmacy, Port Charlotte, FL - 503A Facility

• Warning Letter (09/17/2021)
• 483 Issued 03/16/2020 (PDF - 1 MB)

The Ritedose Corporation, Columbia, SC - 503A Facility

• FMD-145 Letter Issued 09/23/2022
• 483 Issued 03/18/2022 (PDF - 289 KB)

The Sullivan Pharmacy, (see John's Pharmacy, Inc.), Sullivan, IL - 503A Facility

The Wellness Center Pharmacy, Inc., (dba Designer Drugs), Chattanooga, TN - 503A Facility

• Referral Letter to the Tennessee Board of Pharmacy Issued 02/06/2019 (PDF - 54 KB)
• FMD-145 Letter Issued 02/06/2019 (PDF - 47 KB)
• Warning Letter Close Out Issued 02/06/2019

Thrifty White Drug #762, Minneapolis, MN - 503A Facility

• State Referral Letter Issued 05/27/2020
• FMD-145 Letter Issued 05/27/2020 (PDF - 96KB)

Thrive Pharmacy, (see Matthew 7:25 Inc), Jacksonville, FL - 503A Facility

Total Pharmacy Services, Houma, LA - 503A Facility

• State Referral Letter Issued 6/17/2019
• FMD-145 Letter Issued 06/17/2019
• Warning Letter Close Out Issued 06/17/2019

Total Vein Pharmacy, LLC, (dba Total Vein Pharmacy), Houston, TX - 503A Facility

• 483 Issued 05/09/2019 (PDF - 219KB)

Tower Pharmacy and Compounding, (see Botrosons Pharmaceutical Inc.), Mission Viejo, CA - 503A Facility

Town and Country Compounding and Consultation Services LLC, Ridgewood, NJ - 503A Facility

• FMD-145 Letter Issued 08/11/2020 (PDF - 104KB)
• State Referral Letter Issued 08/11/2020
• Warning Letter Close Out Issued 08/11/2020

Triad Isotopes, Inc., (see Jubilant Draximage Radiopharmacies, Inc.), Kansas City, MO - 503A Facility

Triad Rx, Inc., Daphne, AL - 503A Facility

• State Referral Letter Issued 5/3/2023 (PDF - 888KB)
• Warning Letter Close Out Issued 05/03/2023 (PDF - 168KB)
• FMD-145 Letter Issued 05/03/2023
• 483 Issued 12/08/2022 (PDF - 306KB)
• Warning Letter (02/05/2019)

Triangle Compounding, Cary, NC - 503A Facility - De-registered as an Outsourcing Facility

• State Referral Letter Issued 06/17/2020
• Warning Letter Close Out Issued 06/17/2020
• FMD-145 Issued 6/17/2020 (PFD-91 KB)

TSDR Pharmacy, Inc. (dba brandMD Skin Care), Chatsworth, CA - 503A Facility

• Warning Letter Close Out Issued 4/29/2019
• FMD-145 Letter Issued 04/29/2019

United Pharmacy, LLC, West Palm Beach, FL - 503A Facility - Out of business

• Warning Letter (02/11/2019)

University Rx Specialties Inc., San Diego, CA - 503A Facility

• State Handoff Letter Issued 10/08/2021
• FMD-145 Letter Issued 10/08/2021

US Compounding Inc., Conway, AR - 503A Facility - Out of business

• 483 Issued 02/07/2019 (PDF - 2.11MB)

US Specialty Formulations LLC, Allentown, PA - 503B Facility

• 483 Issued 07/02/2024 (PDF - 1.16MB)
• Warning Letter (07/26/2023)
• Amended 483 Issued 04/26/2022 (PDF - 4.14MB)

US Specialty Formulations LLC, Bethlehem, PA - 503B Facility

• 483 Issued 07/23/2019 (PDF - 626KB)

VA New Jersey Health Care System, East Orange, NJ - 503A Facility

• 483 Issued 02/27/2020 (PDF - 885KB)

Valescent Compounding Inc., (dba VPI Compounding), Centennial, CO - 503A Facility 

• FMD-145 Letter Issued 10/14/2021

Valgene Incorporated, (dba Cape Drugs), Annapolis, MD - 503A Facility

• Warning Letter Close Out Issued 01/13/2023
• FMD-145 Letter Issued 01/13/2023
• Untitled Letter Issued 07/20/2022 (PDF - 552KB)
• 483 Issued 12/02/2021 (PDF - 766KB)

Valor Compounding Pharmacy, Inc., dba Valor Compounding Pharmacy, Berkeley, CA - 503A Facility

• State Referral Letter Issued 8/14/2023
• FMD-145 Issued 8/14/2023       
• Untitled Letter Issued 03/23/2023 (PDF - 588KB)
• 483 Issued 09/15/2022 (PDF - 559KB)

Vasco Pharmacy (see Vitalab Pharmacy, Incorporated), Phoenix, AZ - 503A Facility

Village Pharmacy, Allentown, NJ - 503A Facility

 

• Warning Letter Close Out Issued 02/01/2021
• FMD-145 Letter Issued 01/29/2021 (PDF - 88KB)

Vios Compounding, (see SNF Holdings, LLC), Livonia, MI - 503A Facility

Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TX - 503A Facility

• Warning Letter (08/29/2022)
• 483 Issued 11/02/2021 (PDF - 664KB)
• FMD-145 Letter Issued 07/08/2020 (PDF - 208KB)
• 483 Issued 02/11/2020 (PDF - 640KB)

Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TX - 503A Facility

• FMD-145 Letter Issued 05/20/2022
• 483 Issued 10/06/2021 (PDF - 1.24MB)

Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy), Phoenix, AZ - 503A Facility

• Warning Letter Close Out Issued 02/06/2020
• Referral Letter to the Arizona State Board of Pharmacy dated 02/06/2020 (PDF - 79KB)
• FMD-145 Issued 02/06/2020 (PDF - 68KB)
• 483 Issued 08/02/2019 (PDF - 169KB)
• Warning Letter (01/10/2019)

Vital Care Compounder LLC, (see Pharmacy Plus, Inc.), Hattiesburg, MS - 503A Facility

Vital Care of Dickson, Dickson, TN - 503A Facility

• Untitled Letter Issued 08/21/2020 (PDF - 429KB)
• 483 Issued 03/11/2020 (PDF - 405KB)

W & C (dba The Apothecary), Sartell, MN - 503A Facility

• Warning Letter Close Out Issued 10/22/2019
• Referral Letter to the Minnesota State Board of Pharmacy Issued 10/22/2019 (PDF - 128KB)
• FMD-145 Letter Issued 10/22/2019 (PDF - 103KB)

Walfer Corporation dba Wallace Pharmacy (formerly The Medicine Shoppe Pharmacy), Port Charlotte, FL - 503A Facility

• State Handoff Letter Issued 9/20/2022
• Warning Letter Closeout Issued 9/20/2022    
• FMD-145 Letter Issued 9/20/2022

Wedgewood Connect, LLC, San Jose, CA - 503B Facility

• FMD-145 Letter Issued 09/17/2024
• Untitled Letter Issued 04/25/2024 (PDF - 536KB)
• 483 Issued 11/17/2023 (PDF - 1.97MB)
• FMD-145 Letter Issued 04/28/2022
• Amended 483 Issued 12/03/2021 (PDF - 898KB)

Wedgewood Village Pharmacy, Inc., Swedesboro, NJ - 503A Facility - Ceased Compounding Human Drug Products

• FMD-145 Letter Issued 12/21/2022
• Warning Letter Close Out Issued 10/17/2022 (PDF - 206KB)
• FMD-145 Letter Issued 09/12/2022
• FMD-145 Letter Issued 08/08/2022
• 483 Issued 03/24/2022 (PDF - 2.44MB)

Well Care Discount Pharmacy LLC, (dba Well Care Compounding Pharmacy), Las Vegas, NV - 503A Facility

• Warning Letter Close Out Issued 09/17/2020
• State Referral Letter Issued 09/17/2020
• FMD-145 Letter Issued 09/17/2020
• Untitled Letter Issued 07/17/2019 (PDF - 86KB)

WellRx, LLC (dba HomeRx, LLC), Wheaton, IL - 503A Facility

• Referral Letter to the Illinois State Board of Pharmacy Issued 04/03/2019
• FMD-145 Letter Issued 04/03/2019

Wells Pharmacy Network, LLC, Ocala, FL - 503A Facility

• FMD-145 Letter Issued 06/8/2020 (PDF-165KB)

Wells Pharmacy Network LLC, Dyersburg, TN - 503B Facility

• Untitled Letter Issued 05/19/2022 (PDF - 315KB)
• 483 Issued 01/28/2021 (PDF - 4.5MB)
• FMD-145 Letter Issued 08/06/2020 (PDF - 67KB)
• FMD-145 Letter Issued 04/15/2020 (PDF - 119 KB)

Wells Pharma of Houston LLC, Houston, TX - 503B Facility

• FMD-145 Letter Issued 4/18/2023
• 483 Issued 12/14/2022 (PDF - 611KB)
• FMD-145 Letter Issued 01/10/2022
• 483 Issued 06/17/2021 (PDF - 240KB)

Westchester Compounding Pharmacy Inc., Eastchester, NY - 503A Facility

• State Handoff Letter Issued 02/28/2023
• FMD-145 Letter Issued 02/28/2023

West Coast Nuclear Pharmacy, LLC, Tampa, FL - 503A Facility

• Warning Letter (10/06/2020)

Westlab Pharmacy, Inc., (dba Westlab Pharmacy), Gainesville, FL - 503A Facility

• Warning Letter Close Out Issued 01/10/2023
• State Referral Letter Issued 01/10/2023
• FMD-145 Letter Issued 01/10/2023
• 483 Issued 10/05/2021 (PDF - 908KB)
• Warning Letter (06/26/2019)

White House Pharmacy, Inc., (dba San Jose Compounding Pharmacy), San Jose, CA - 503A Facility

• State Handoff Letter Issued 12/21/2021
• FMD-145 Letter Issued 12/21/2021

Wise Pharmacy, (see Joe Wise Pharmacy, Inc.), Littleton, CO - 503A Facility

Woodland Hills Compounding Pharmacy, (see Algunas, Inc.), Woodland Hills, CA - 503A Facility

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Active Ingredient Suppliers

Professional Compounding Centers of America, dba PCCA, Houston, TX

• Warning Letter (01/27/2021)

Related Information

• Compounding

Resources 

• See FDA's Enforcement Report to Search Recalls, Including Compounded Drug Products 
• Inspections, Recalls, and Other Actions with Respect to Firms that Engage in Animal Drug Compounding