FDA 483 - J.M. Huber Micropowders, Inc - December 05, 2025

J.M. Huber Micropowders, Inc., a Drug API Manufacturer in Quincy, IL, was cited for two significant observations. The firm failed to conduct adequate investigations into out-of-specification (OOS) products and raw materials, including invalidating OOS results without proper protocols and releasing OOS material. Additionally, the company did not maintain adequate records to assure CGMP compliance, specifically regarding disabled audit trails on critical analytical instruments and a lack of procedures for their review.