U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Maryland Specialty and Compounding Pharmacy, LLC (formerly Professional Arts - 518272 - 03/11/2019
  1. Warning Letters

CLOSEOUT LETTER

Maryland Specialty and Compounding Pharmacy, LLC (formerly Professional Arts MARCS-CMS 518272 —

Delivery Method:
UPS Overnight
Recipient:
Recipient Name
Simeon Georgiou
Recipient Title
Owner
Maryland Specialty and Compounding Pharmacy, LLC (formerly Professional Arts
Maryland Specialty and Compounding Pharmacy

2015 Lord Baltimore Dr.
Baltimore, MD 21244
United States

Issuing Office:
Center for Drug Evaluation and Research

United States

Dear Mr. Georgiou:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL # 518272) dated April 3, 2017. We acknowledge that your firm no longer produces sterile drug products. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. If you decide to resume production of drug products intended to be sterile, FDA strongly recommends that you undertake a comprehensive assessment of your operations, including facility design, and that you notify FDA prior to resuming sterile production. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

If you have questions regarding the contents of this letter, please contact Juan Jiménez, Compliance Officer, by telephone at 518-453-2314 X-1014, or by email at Juan.Jimenez@fda.hhs.gov.

Sincerely,
/S/
Diana Amador-Toro
Program Division Director
Office of Pharmaceutical Quality Operations – Division I

Cc:   Maryland Specialty and Compounding Pharmacy, LLC 
         Previously dba Professional Arts Pharmacy
         2015 Lord Baltimore Dr.
         Baltimore, MD 21244

Back to Top