FDA 483 - Protherics UK Limited - August 13, 2024

Protherics UK Limited, a biological drug substance manufacturer in Llandysul, United Kingdom, was cited for failing to fully investigate and assess the impact of recurring mold contamination in a room used for manufacturing materials and stability samples. The firm's quality investigations and corrective actions were deemed insufficient, with inadequate environmental monitoring and a limited scope of investigation into the root cause. This indicates a significant lapse in quality control and contamination prevention practices.