FDA 483 - Belleview 402 LLC - March 15, 2024

An FDA inspection conducted at Wittman Pharma Inc. in Brooksville, FL, from February 6 to March 15, 2024, revealed significant deviations from Current Good Manufacturing Practices (CGMP) for drug manufacturers, resulting in a Form FDA 483. The inspection highlighted critical shortcomings in the firm's quality control systems and manufacturing processes, with several observations noted as repeats from previous inspections. Key issues included the absence of a properly established and followed quality control unit with adequate CGMP knowledge and oversight. The company failed to implement sufficient microbial controls for water used in liquid over-the-counter (OTC) drug products, despite historical recoveries of objectionable organisms and out-of-specification results. Furthermore, finished product testing was incomplete prior to the release and distribution of OTC drugs. The firm's water system, used in products for children, was not adequately qualified to consistently produce pharmaceutical-grade water, showing persistent microbial contamination. Additional observations noted incomplete cleaning validation for manufacturing equipment, deficiencies in laboratory controls such as insufficient microbial suitability testing and bulk product hold time studies, and inadequate identification testing of raw materials. Wittman Pharma Inc. must promptly address these serious observations to ensure product quality, safety, and compliance with regulatory standards.