FDA 483 - J.M Huber Micropowders, Inc - June 25, 2021

An FDA inspection of J.M Huber Micropowders, Inc. in La Mirada, CA, revealed significant deficiencies in their manufacturing processes for non-sterile API. The firm was cited for producing batches using unsupported validation data, failing to document deviations, and not calibrating critical equipment. Additionally, the inspection found that GMP-related computerized systems lacked proper validation, indicating a need for improved quality control and adherence to regulatory standards.