McGuff Pharmaceuticals, Inc. – FDA 483, Apr 28, 2025

McGuff Pharmaceuticals, Inc. in Santa Ana, CA, a sterile drug manufacturer, was cited for significant deficiencies in its aseptic processing controls and quality unit operations. The inspection revealed a lack of written procedures for preventing microbiological contamination, inadequate cleanroom evaluation, and poor environmental monitoring. Additionally, the quality control unit failed to establish written responsibilities, properly review changes, release raw materials, or adequately investigate discrepancies and evaluate corrective actions.