San Diego Compounding Pharmacy MARCS-CMS 520259 —
- Delivery Method:
- VIA UPS
SIGNATURE CONFIRMED DELIVERY
Recipient NameJerome A. Greene
- San Diego Compounding Pharmacy
5395 Ruffin Road
San Diego, CA 92123-1338
- Issuing Office:
- Center for Drug Evaluation and Research
19701 Fairchild Road
Irvine, CA 92612-2506
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.
CDR Steven E. Porter Jr.
Director, Division of Pharmaceutical Quality Operations IV