TSDR Pharmacy Inc. dba brandMD Skin Care - 540960 - 04/29/2019
- Delivery Method:
- VIA UNITED PARCEL SERVICE
Recipient NameSamuel D. Raoof
Recipient TitleCEO and President
- TSDR Pharmacy Inc. dba brandMD Skin Care
20660 Nordhoff Street
Chatsworth, CA 91311-6114
- Issuing Office:
- Center for Drug Evaluation and Research
Irvine, CA 92612-2506
Dear Mr. Raoof:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s response to our warning letter dated November 9, 2017. We acknowledge that your California state-issued pharmacy license (PHY 50543) has been cancelled and that your facility is closed.
If you decide to resume production of drug products, FDA strongly recommends that you undertake a comprehensive assessment of your operations, and that you notify FDA prior to resuming drug production. You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV