FDA 483 - J.M Huber Micropowders, Inc - February 11, 2026

J.M. Huber Micropowders, Inc. in La Mirada, CA, received a Form 483 with three observations related to manufacturing process control, stability testing, and laboratory data integrity. The firm failed to demonstrate reproducible manufacturing processes, lacked an adequate stability testing program, and exhibited insufficient controls over laboratory systems, including data access and documentation. These issues indicate significant concerns regarding product quality and data reliability.