Akron Formulations India Private Limited – FDA Warning Letter, Oct 15, 2024

The FDA issued a Warning Letter to Akron Formulations India Private Limited, an OTC drug manufacturer, following a review of records submitted per section 704(a)(4) of the FD&C Act. The letter, dated December 17, 2024, identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Quality Control Unit (QCU) (21 CFR 211.22(a)):** The firm failed to adequately qualify Active Pharmaceutical Ingredient (API) suppliers. They used APIs from three suppliers (b)(4), (b)(4), and (b)(4) that were under FDA Import Alerts (66-40, 99-32, 66-79) at the time of manufacturing and shipment to the U.S. Specific issues included one supplier's failure to validate water systems, using river water subject to agricultural runoff and stored in an open tank.

2. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** The firm lacked scientifically sound specifications and test procedures. * **Inadequate Drug Product Testing:** Numerous batches, including OneLAX Docusate Sodium Liquid Stool Softener Laxative, were