FDA EIR - Pharmaceutics International, Inc. - September 29, 2021

An FDA inspection of Pharmaceutics International, Inc. in Cockeysville, MD, was conducted from July 26 to September 29, 2021. The inspection combined current Good Manufacturing Practices (cGMP) surveillance with a Pre-Approval Inspection (PAI) for several New Drug Applications and Abbreviated New Drug Applications, adhering to Compliance Program Guidance Manuals for PAI and Sterile Drug Process Inspections. The inspection identified ten significant deficiencies, many of which were recurring observations from prior inspections, leading to an Official Action Indicated (OAI) classification. Key violations included the failure to thoroughly review unexplained discrepancies and batch failures, inadequate adherence to quality control unit procedures, and insufficient measures to prevent microbiological contamination of sterile drug products. Additionally, issues were noted with controls over computer systems for master record changes, instrument calibration, electronic equipment checks, and deficient equipment cleaning and maintenance procedures. Building construction and aseptic processing areas, particularly ceilings, were deemed unsuitable for proper cleaning, and control systems to prevent contamination or mix-ups were found deficient. Consequently, the FDA issued a "Withhold" recommendation for all pending applications. Company management acknowledged the findings and committed to submitting a written response outlining their corrective actions within 15 business days.