FDA 483 - Jost Chemical Co. - January 21, 2022

Jost Chemical Co., an API manufacturer in Saint Louis, was cited for significant deficiencies across multiple areas during an FDA inspection. The firm failed to adequately investigate out-of-specification results and customer complaints, particularly concerning microbiological contamination. Additionally, the inspection revealed issues with equipment cleaning, data integrity controls for computer systems, lack of essential written procedures, and incomplete laboratory control records.