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  5. The Wellness Center Pharmacy, Inc., dba Designer Drugs - 496523 - 02/06/2019
  1. Warning Letters

CLOSEOUT LETTER

The Wellness Center Pharmacy, Inc., dba Designer Drugs MARCS-CMS 496523 —

Product:
Drugs

Recipient:
Recipient Name
Randal J. Davis
Recipient Title
President
The Wellness Center Pharmacy, Inc., dba Designer Drugs

7304 Jarnigan Road
Chattanooga, TN 37421
United States

Issuing Office:
Center for Drug Evaluation and Research

4040 N. Central Expressway
Suite 300
Dallas, TX 75204
United States


Dear Mr. Davis:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #2016-NOL-11 dated August 5, 2016. 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/
Jose R. Lopez
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations
Division II