FDA EIR - Pharmaceutics International, Inc. - November 09, 2018

An FDA inspection of Pharmaceutics International, Inc. in Cockeysville, MD, was conducted from October 24 to November 9, 2018. This comprehensive review, under regulatory frameworks including CPGM 7356.002 for drug manufacturing and various pre/post-approval and medical device inspection guidelines, scrutinized the company's quality, production, materials, facilities and equipment, and laboratory systems. The inspection resulted in eleven formal observations on an FDA-483 form and five verbal observations. Key issues identified included inadequate validation of aseptic processes and environmental monitoring, with deficiencies such as dried media plates and insufficient incubation times. Problems were also noted with personnel training, particularly for visual inspectors, and a lack of procedures for utilizing environmental isolates. The quality control unit demonstrated failures in following procedures, reviewing discrepancies, and managing the timely closure of quality events. Equipment maintenance, including calibration and integrity (e.g., rouging on equipment), was found deficient, alongside inadequate documentation and process validation. Management acknowledged all observations and committed to providing a written response with proposed corrective actions within fifteen business days, highlighting the need for sustained improvements to their Good Manufacturing Practices (cGMP) compliance.