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CLOSEOUT LETTER

San Diego Compounding Pharmacy MARCS-CMS 520259 —

Delivery Method:
VIA UPS
SIGNATURE CONFIRMED DELIVERY
Product:
Drugs

Recipient:
Recipient Name
Jerome A. Greene
Recipient Title
Owner/Pharmacist
San Diego Compounding Pharmacy

5395 Ruffin Road
Suite 104
San Diego, CA 92123-1338
United States

Issuing Office:
Center for Drug Evaluation and Research

19701 Fairchild Road
Irvine, CA 92612-2506
United States

949-608-2900

Dear Mr. Greene:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [CMS# 520259, September 25, 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. 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