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  5. RC Compounding Services, LLC - 393791 - 09/12/2019
  1. Warning Letters

CLOSEOUT LETTER

RC Compounding Services, LLC MARCS-CMS 393791 —

Delivery Method:
UPS Next Day
Reference #:
CIN-14-393791-17
Product:
Drugs
Recipient:
Recipient Name
Raymond R. Carlson, RPh
Recipient Title
Owner/Pharmacist
RC Compounding Services, LLC

3030 Center Road
Poland, OH 44514
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

300 River Place
Suite 5900
Detroit, MI 48207
United States

(313) 393-8100

Dear Mr. Carlson,

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 July 14, 2014 (CIN-14-393791-17). 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 ensure 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/
Nicholas F. Lyons
Director Compliance Branch
Division of Pharmaceutical Quality Operations III

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