Triad Rx, Inc.

CLOSEOUT LETTER Triad Rx, Inc. MARCS-CMS 569659 — May 03, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail Return Confirmation Requested Product: Drugs Recipient: Recipient Name Matt McDonald Recipient Title Owner Triad Rx, Inc. 26258 Pollard Rd. Daphne , AL 36526-4250 United States Issuing Office: Division of Pharmaceutical Quality Operations II United States Dear Mr. McDonald: 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 569659 Issued February 5, 2019]. 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 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/ Ronda R. Loyd-Jones Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 07/05/2023 Regulated Product(s) Drugs