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  5. W & C dba The Apothecary - 508183 - 10/22/2019
  1. Warning Letters

CLOSEOUT LETTER

W & C dba The Apothecary MARCS-CMS 508183 —

Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Stephen G. Anderson, R. Ph.
Recipient Title
Owner
W & C dba The Apothecary

165 19th Street South
Suite 102
Sartell, MN 56377-2567
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III (PHRM3)

300 River Place
Suite 5900
Detroit, MI 48207
United States

(313) 393-8100

Dear Mr. Anderson:

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 20, 2017, (Case #508183). 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/
Nicholas F. Lyons
Director Compliance Branch
Division of Pharmaceutical Quality Operations III

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