FDA 483 - Protherics UK Limited - August 13, 2024

An FDA inspection of Protherics UK Limited, a biological drug substance manufacturer, revealed a significant issue with mold contamination. The firm failed to fully investigate the presence of various molds in a room holding manufacturing materials and stability samples, including inadequate environmental monitoring and a lack of assessment for similar HVAC units. This indicates a potential risk of cross-contamination and raises concerns about the firm's quality event management.