CLOSEOUT LETTER
Drug Depot, Inc., dba APS Pharmacy MARCS-CMS 501069 —
- Delivery Method:
- UPS Overnight
- Product:
- Drugs
- Recipient:
-
Recipient NameJaime A. Rios
-
Recipient TitleCo-Owner and President
- Drug Depot, Inc., dba APS Pharmacy
34911 US Highway 19 N Ste 600
Palm Harbor, FL 34684-1921
United States
- Issuing Office:
- Center for Drug Evaluation and Research
4040 N. Central Expressway
Suite 300
Dallas, TX 75204
United States
Mr. Rios:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL # FLA-17-02; December 15, 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 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/
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II