FDA 483 - CFB Michigan Inc - October 17, 2024

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.