- Delivery Method:
- UPS EXPRESS
Recipient NameVictor A. Poteet, PharmD.
Recipient TitleChief Executive Officer
- The Compounding Pharmacy of America
6216 Highland Place Way
Knoxville, TN 37919-4068
- Issuing Office:
- Center for Drug Evaluation and Research
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
- (615) 366-7801
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter dated June 9, 2016 [WL # 2016-NOL-08]. 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.
If you have any further questions, you may contact me at (214) 253-5288.
LCDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,