CFB Michigan Inc – FDA 483, Oct 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.
ID · dc92f339-a471-478c-b047-d19e50cfbdba
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