FDA 483 - Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. - October 30, 2024

An FDA inspection of Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc., a manufacturer of OTC drug products in Santa Fe Springs, CA, revealed significant deficiencies in their production and quality control systems. The firm failed to validate manufacturing processes, properly calculate yields, ensure reliable stability test methods, and thoroughly investigate out-of-specification results. Additionally, the quality control unit lacked authority to review production records for completeness.