FDA 483 - COSMOBEAUTI LABORATORIES & MANUFACTURING, INC. - March 15, 2023

COSMOBEAUTI LABORATORIES & MANUFACTURING, INC., a contract drug manufacturer in San Dimas, CA, was cited for numerous significant Good Manufacturing Practice (GMP) deficiencies during an FDA inspection. The inspection revealed repeat observations from a previous inspection, highlighting systemic failures in batch recordkeeping, quality unit oversight, investigation of discrepancies, stability testing, component control, process validation, and facility sanitation. These issues indicate a severe lack of control over drug product manufacturing and quality assurance for sunscreens and hand sanitizers.