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  5. TSDR Pharmacy Inc. dba brandMD Skin Care - 540960 - 04/29/2019
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CLOSEOUT LETTER

TSDR Pharmacy Inc. dba brandMD Skin Care MARCS-CMS 540960 — Apr 29, 2019

TSDR Pharmacy Inc. dba brandMD Skin Care - 540960 - 04/29/2019

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Cosmetics
Drugs

Recipient:
Recipient Name
Samuel D. Raoof
Recipient Title
CEO and President
TSDR Pharmacy Inc. dba brandMD Skin Care

20660 Nordhoff Street
Chatsworth, CA 91311-6114
United States

Issuing Office:
Center for Drug Evaluation and Research

19701 Fairchild
Irvine, CA 92612-2506
United States

949-608-2900

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.

Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV