- Delivery Method:
- Via Electronic Mail Return Confirmation Requested
Recipient NameMatt McDonald
- Triad Rx, Inc.
26258 Pollard Rd.
Daphne, AL 36526-4250
- Issuing Office:
- Division of Pharmaceutical Quality Operations II
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.
Ronda R. Loyd-Jones
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,