Drug Depot, Inc., dba APS Pharmacy

CLOSEOUT LETTER Drug Depot, Inc., dba APS Pharmacy MARCS-CMS 501069 — September 20, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Product: Drugs Recipient: Recipient Name Jaime A. Rios Recipient Title Co-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 Content current as of: 10/24/2019 Regulated Product(s) Drugs