Maryland Specialty and Compounding Pharmacy, LLC (formerly Professional Arts

CLOSEOUT LETTER Maryland Specialty and Compounding Pharmacy, LLC (formerly Professional Arts MARCS-CMS 518272 — March 11, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 03/18/2019