San Diego Compounding Pharmacy

CLOSEOUT LETTER San Diego Compounding Pharmacy MARCS-CMS 520259 — July 08, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 07/12/2019 Regulated Product(s) Drugs