The Compounding Pharmacy of America

CLOSEOUT LETTER The Compounding Pharmacy of America MARCS-CMS 476703 — November 07, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS EXPRESS Recipient: Recipient Name Victor A. Poteet, PharmD. Recipient Title Chief Executive Officer The Compounding Pharmacy of America 6216 Highland Place Way Suite 201-B Knoxville , TN 37919-4068 United States Issuing Office: Center for Drug Evaluation and Research United States (615) 366-7801 Dr. Poteet: 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. Sincerely, /S/ LCDR John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 03/04/2019