Shadow Holdings DBA Bocchi Labs MARCS-CMS 561273 — February 06, 2019

WARNING LETTER

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• Recipient: Mr. Joseph C. Pender; CEO/President; Shadow Holdings DBA Bocchi Labs ; 26421 Ruether Ave; Santa Clarita, CA 91350-2621; United States

• Issuing Office: Los Angeles District Office; United States

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WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

February 6, 2019

WL #561273

Mr. Joseph C. Pender, CEO/President
Shadow Holdings LLC dba Bocchi Laboratories
26421 Ruether Ave
Santa Clarita, CA 91350-2621

Dear Mr. Pender:

The United States Food and Drug Administration (FDA) conducted an inspection of your Shadow Holdings LLC dba Bocchi Laboratories, cosmetic and Over the Counter (OTC) drug manufacturing facility located at 26421 Ruether Ave, Santa Clarita, CA 91350 from March 29 through June 7, 2018. The inspection was conducted in response to an outbreak of Burkholderia cepacia associated with Medline Remedy Essentials Cleanser No-Rinse Foam, a cosmetic you manufacture that is intended for use in hospital settings, and to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act). Based on our inspection, we found significant violations of the Act. You may find the Act and its implementing regulations through links on FDA's home page at http://www.fda.gov.

Adulterated Cosmetics

Your firm is a contract manufacturer for various products, including no-rinse cleanser foam, face wash, lotion, moisturizer, hair styling cream, shampoo, and conditioner. These products that you manufacture, pack, and label are intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, and as such, they are cosmetiCs within the meaning of section 201(i) of the Act [21 U.S.C. 321(i)]. The microbial contamination of the Medline Remedy Essentials Cleanser No-Rinse Foam product causes this product to be adulterated within the meaning of section 601(a) of the Act [21 U.S.C. 361(a)], as described further below. Furthermore, the conditions observed during the inspection cause Medline Remedy Essentials Cleanser No-Rinse Foam and other cosmetics manufactured in your facility to be adulterated within the meaning of section 601(c) of the Act [21 U.S.C. 361(c)], as described further below. It is a violation of Section 301(a) of the Act [21 U.S.C. 331(a)] to introduce or deliver for introduction into interstate commerce an adulterated cosmetic.

1. The Medline Remedy Essentials brand Cleanser No-Rinse Foam that you manufacture is adulterated within the meaning of section 601(a) of the Act [21 U.S.C. § 361(a)]. Under section 601(a) of the Act [21 U.S.C. 361(a)], a cosmetic is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. Our investigator collected samples of your Medline Remedy Essentials brand Cleanser No-Rinse Foam from lots Mo7247 and Mo6691 and these samples were found by FDA laboratory analysis to contain the pathogen Burkholderia cepacia, which may render the product injurious to health. People exposed to Burkholderia cepacia are at an increased risk for illness or infection, especially people who might have weakened immune systems or other underlying medical conditions. This product is used in hospitals and home-health care settings, and therefore poses a health risk to users under customary or usual conditions of use.

We acknowledge that you have recalled several cosmetics products due to potential microbiological contamination. Specifically, you initiated a recall on March 28, 2018, for Medline Remedy Essentials Cleanser No-Rinse Foam due to potential contamination with Burkholderia cepacia. You later initiated a second recall on May 8, 2018, for nineteen cosmetic products due to potential contamination with Burkholderia cepacia. You initiated a recall for Super Sculpt Glaze on December 11, 2018, for potential contamination with Burkholderia cepacia. It is your firm's responsibility to identify any other products that may be adulterated and could lead to illnesses.

2. The cosmetic products you manufacture are adulterated within the meaning of section 601(c) of the Act [21 U.S.C. § 361(c)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Specifically,

a. On March 29, 2018, April 23, 2018, April 26, 2018, and May 3, 2018, the FDA collected environmental swabs from the production area and product contact areas, as well as water samples. FDA laboratory analysis of these samples found contamination with Burkholderia cepacia, Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonasfiuorescens, Pseudomonas oryzihabitans, other Pseudomonas spp., Enterobacter gergoviae, and several other microbiological organisms. These microorganisms in the water, production area, and other product contact areas could contaminate your cosmetic products, which may render them injurious to health.

b. Your firm released finished cosmetic products such as Remedy Essential No-Rinse Cleansing Foam that did not meet your finished product specification limits for Aerobic Plate Count (APC) of "(b)(4) cfu/ gm" and Yeast & Mold (Y&M) of "(b)(4) cfu/gm". Specifically, your test results showed "TNTC" [Too Numerous to Count] for both Aerobic Plate Count and Yeast & Mold for two lots of Remedy Essential No-Rinse Cleansing Foam, but you released those two lots and did not investigate or identify the source of the elevated microbial counts.

c. Our investigators observed insanitary practices that may lead to insanitary conditions that may cause your products to be contaminated with filth or rendered injurious to health. Specifically, you do not adequately maintain your equipment or facility to prevent contamination of cosmetic products. Investigators observed the following:

i.  Liquid dripping from a crack on the bottom side of (b)(4) tank (b)(4) located in the compounding area. This tank is used to manufacture (compounding/blending) your firm's in-process cosmetic products including lotions and hair styling cream.
ii. Liquid leaking from the outlet port on the bottom side of (b)(4) tank (b)(4) in the compounding area. This tank is used to manufacture (compounding/blending) your firm's in-process cosmetic products including shampoo, conditioner, no rinse cleansing foam, lotions, skin cream and hair styling cream.
iii. Vents directly above the (b)(4) tanks on the (b)(4) of the compounding area were blackened and dirty. Black debris was observed on palletized raw materials that had been placed directly below the vent.
iv. The ventilation system above the (b)(4) was broken. Your firm did not provide information regarding how long it has been broken and did not have any maintenance records or plans to repair the ventilation system. The (b)(4) curtains for the (b)(4) were not used as intended. The (b)(4) curtains were placed on top of the (b)(4). Dust and debris were observed on the (b)(4) curtains. These (b)(4) are used for weighing and staging of raw materials for manufacturing operations.
v. Heavy buildup of dust, debris, and a live fly-like insect inside the (b)(4) and in the staging area in front of the (b)(4). These (b)(4) held open, exposed bags of raw materials.
vi. A live bird flying in the raw materials warehouse facility. Your firm kept the rolling doors open at the loading dock area.
vii. Chipped and missing pieces of the conveyor belt on Production Filler Line (b)(4) This production filler line (b)(4) is used to fill in-process and package finished cosmetic products including shampoo, conditioners, and no rinse cleansing foam.
viii. Flooding of wastewater in the compounding area floor due to a nonfunctional 2-inch floor drain. Water hoses were submerged in the wastewater on the pitted and cracked floors in the compounding area. The hoses are used for production, cleaning, and sanitation operations. Additionally, the hoses were observed to be worn and frayed. Your firm did not have any maintenance records or plans to repair the floor drain and floors, nor to replace the water hoses.
ix. Green colored tape was used to wrap a handle that turns on/ off hot water on Production Filler Line (b)(4). The tape was stripping off. Tape is not easily cleanable and can be a reservoir for microbial pathogens.
x. A gray-like residue was adhering to the product contact surfaces of the Teflon pump and housing cover of an unidentified (b)(4). Pump used on Filling Line (b)(4). The pump was tagged by production to be clean, sanitized, and ready for use.
xi. A gray-like film was adhering to one of the filling nozzles located on Linc (b)(4) a product contact surface. The filling nozzles of Line (b)(4) were tagged by production to be clean, sanitized and ready for use
xii. You rely on (b)(4)) testing to verify the effectiveness of your cleaning and sanitation. However, on March 29, 2018, FDA collected 51 environmental swab samples on various areas of your manufacturing floor. 19 out of the 51 swabs tested positive for the following microorganisms: Burkholderia spp., Pseudomonas spp., and Enterobacter spp. Subs 1, 4, 7, 10, and 12 were taken on Line (b)(4) and Line (b)(4) surfaces that were purportedly cleaned and sanitized per your firm's "Cleaning, Sanitizing and Set Up Log."

We acknowledge receipt of your written responses dated June 27, 2018, and August 24, 2018. You state that you have hired a consultant to assist with reviewing your quality system, implementing improvements, and cleaning and sanitizing your facility. Specifically, you state that you have, among other actions, repaired leaking valves, cleaned vents, increased housekeeping efforts, cleaned the (b)(4), addressed gaps in the bay doors, created a seal around the dock exterior shelters, replaced the conveyer belt for production filler line (b)(4), repaired the non-functioning drain, replaced water hoses, replaced the peeling green tape on the handle for production filler line (b)(4) sanitized line (b)(4), and developed an environmental monitoring plan. You provided new or revised Standards of Procedure (SOPs) and training records. We will evaluate the sufficiency of your corrective actions at the next inspection.

Adulterated Drugs

This warning letter also summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

You manufactured Acne Shave Cream, Acne Shave Moisturizer and X-Jow Pain Gel. These products are "drugs" as defined by section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the Act [21 U.S.C. 321(g)(1)(C)], because they are intended to affect the structure or any function of the body.

Evidence that establishes the intended use of these products as drugs includes, but may not be limited to, the following claims observed on your products' labels:

Acne Shave Cream
"ACNE SHIELD ... Treats Acne while Shaving ... acne treatment ... "

Acne Shave Moisturizer
"ACNE CONTROL ... controls acne breakouts ... Acne medication ... "

X-Jow Pain Gel
"PAIN GEL. .. FAST AND SUSTAINABLE RELIEF FOR JOINT AND MUSCLE INJURIES ... Temporary relief from minor aches and pains of sore muscles and joints ... "

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C. 351(a)(2)(B)].

During our inspection, our investigators observed specific violations including, but not limited to, the following.

CGMP Violations

1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

Your quality unit did not exercise its authority and responsibilities as demonstrated by the following:
• Your quality unit failed to ensure your water system, used to manufacture components of OTC drugs, was suitable for use. The water system is fundamentally flawed and produced water contaminated with high levels of microorganisms, including the objectionable organism Pseudomonas aeruginosa.
• Your quality unit was aware of failing microbial results for water samples, in which microbial contamination was recorded at a level of too numerous to count (TNTC). Despite this, your quality unit did not exercise appropriate authority to reject components and instead continued to manufacture OTC drugs using water from this system as a component of your drug products.
• Your quality unit failed to initiate investigations into failing test results and implement corrective actions as a result of these findings.

Recall Initiated and Future Drug Manufacturing Plans
We acknowledge that your firm initiated a recall of all OTC drug product batches that were within expiration at the time of the inspection. You also stated in your June 27, 2018 response that you "ceased all drug manufacturing operations" and "[t]herefore, those observations that relate to CGMP compliance are no longer relevant" to your operations. You did not commit to any corrective actions regarding the drug CGMP violations observed on the inspection.

If you plan to resume manufacturing drug products, contact this office in writing to discuss your drug CGMP remediation activities. In addition, in the event you consider resuming drug manufacturing, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting drug CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and effectiveness of corrective actions and preventive actions you have implemented before you pursue resolution of your firm's compliance status with FDA. Using a consultant cloes nol relieve your firm's obligation to comply with CGMP.

Conclusion

This letter is not intended to be an all-inclusive list of violations in connection with your products or your facility. It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations. We advise you to develop a plan for preventing the recurrence of these violations or the occurrence of other violations. We request that you take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.

In addition to the above violations, we also have the following comments. Our inspection revealed the following practices that may cause your products to become contaminated with filth or rendered injurious to health. Specifically, we observed that:

• Your firm uses an in-house laboratory to analyze microbial limits and total organic carbon levels of (b)(4), a raw material that you process and use in the manufacturing of your products. However, on multiple occasions your firm continued to manufacture and distribute finished cosmetic products using (b)(4) that exceeded your firm's "Alert and Action" limit for your Total Aerobic Count of "Alert limit: (b)(4) cfu/mL; Action limit: (b)(4) cfu/mL" and for your Total Organic Carbon (TOC) of "not more than (b)(4) ppb." We note that FDA's Draft Guidance for Industry on Cosmetic Good Manufacturing Practices (available at http://www.fda.gov/downloads/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/UCM358287.pdf) recommends that raw materials be sampled and tested for conformance with specifications and to ensure the absence of filth, microorganisms, and other adulterants prior to processing or usage. The guidance also recommends that laboratory control records for raw materials should include interpretation of the test results (accepts or rejects).

• During the inspection, we observed that there were no hand washing stations throughout the production facilities including the (b)(4) compounding, and in-process product filling areas. In response, you have installed hand sanitizers in product contact areas. We note that FDA's Draft Guidance for Industry on Cosmetic Good Manufacturing Practices (available at http://www.fda.gov/downloads/Cosmetics/GuidanceComplianceRegulatoryinformation/GuidanceDocuments/UCM358287.pdf) recommends that buildings provide adequate washing facilities for sanitary operation and personal cleanliness. We note that hand sanitizer is effective for sanitizing clean hands but does not replace soap and water as a hand wash because sanitizer cannot remove all contaminants.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Your written response should be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild
Irvine, CA 92612

Refer to Unique Identification Number (CMS#561273) when replying.

If you have any questions regarding this letter, please contact Sara J. Dent Acosta, Compliance Officer, at sara.dent@fda.hhs.gov or (619) 941-3767.

Sincerely,
/S/

Darla Bracy, Division Director
Office of Human and Animal Foods
Division 5 West
 

 

Cc:
Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435