FDA 483 - McGuff Pharmaceuticals, Inc. - January 26, 2024

During an inspection from January 16-26, 2024, the FDA issued a Form 483 to McGuff Pharmaceuticals, Inc., a sterile drug manufacturer in Santa Ana, CA, citing significant observations indicating non-compliance with Current Good Manufacturing Practices (cGMP). The findings highlighted systemic deficiencies across multiple areas.

Key violations included a failure within the Quality System to thoroughly investigate critical discrepancies, such as consecutive biological indicator failures during decontamination cycles and continuous particle monitoring excursions in the sterile filling line. Corrective actions were not implemented or closed in a timely manner, and critical component design changes lacked proper change control and scientific justification. The firm's visual inspection program was deemed inadequate due to undefined defect categories, missing acceptance criteria, and unreliable inspector qualification methods.

Further observations revealed failures in the Laboratory System, specifically non-adherence to established test procedures, including incorrect media incubation times for environmental monitoring growth promotion tests, which could compromise microbial detection. Employee training was also deficient, lacking adequate records, defined on-hands aseptic processing training, and effectiveness evaluations. Additionally, the Facilities and Equipment system showed a lack of comprehensive sanitation documentation for internal warehouse monitoring.

McGuff Pharmaceuticals is required to address these observations by implementing robust corrective and preventive actions to ensure compliance and maintain the quality, purity, and strength of its sterile drug products.