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CLOSEOUT LETTER

The Compounding Pharmacy of America MARCS-CMS 476703 — Nov 07, 2018

The Compounding Pharmacy of America - 476703 - 11/07/2018

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

404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
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