FDA 483 - CFB Michigan Inc - October 17, 2024
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.
CFB Michigan Inc, a manufacturer of hand sanitizer drug products in Edwardsburg, MI, was cited for significant deficiencies in its quality control unit, manufacturing processes, and laboratory controls. The inspection revealed a lack of essential procedures for component testing, stability programs, record-keeping, and process validation, indicating a severe breakdown in GMP compliance. The firm also failed to adequately test drug product components and finished products for identity and strength, and its water system was improperly designed.
ID · dc92f339-a471-478c-b047-d19e50cfbdba