FDA 483 - Jost Chemical Co. - January 21, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 9bbf1ada-882a-4177-bc6d-8be98a682a5f