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

McGuff Pharmaceuticals, Inc. in Santa Ana, CA, a sterile drug manufacturer, received a Form 483 with six observations highlighting significant deficiencies across its quality systems. The inspection revealed inadequate investigations into manufacturing discrepancies, including decontamination cycle failures and particle monitoring excursions, and a failure to timely implement corrective actions. Further issues included an unreliable visual inspection program, unrecorded deviations from production procedures, insufficient employee training, and a lack of adherence to microbial monitoring test procedures and sanitation program documentation.