FDA 483 - Jost Chemical Co. - August 14, 2025

An FDA inspection conducted from August 4-14, 2025, at a pharmaceutical manufacturing firm located at 8050 Marshall Drive, Lenexa, KS, revealed significant non-compliance with Current Good Manufacturing Practices. The inspection identified four primary areas of concern requiring immediate attention. Firstly, the firm's stability testing program was found to be deficient. It lacked established protocols for Active Pharmaceutical Ingredients, failed to include critical quality attributes like impurities and endotoxins in testing, and exhibited inadequate storage conditions with observed temperature and humidity excursions. Secondly, the firm's investigation processes were inadequate for critical deviations and out-of-specification results. Multiple investigations (e.g., for microbial contamination and foreign particulate matter) were cited for lacking scientific justification, failing to identify root causes, or not extending to all potentially impacted batches, with this being a repeat observation. Thirdly, customer complaints were not adequately investigated. Instances were noted where investigations attributed issues like out-of-specification loss on drying to customer handling or sampling discrepancies without thoroughly examining manufacturing processes or validating sampling methods, also a repeat observation. Finally, the firm demonstrated failures in contamination control. Deficiencies included inadequate water quality monitoring, cross-contamination risks due to hose usage without proper cleaning, observed algae buildup and leaks in the purified water system, and numerous unaddressed out-of-specification cleaning verification events where products were released. The firm is required to address these observations comprehensively to ensure compliance with federal regulations and prevent recurrence of these quality and manufacturing control deficiencies.