FDA 483 - Protherics UK Limited - August 13, 2024
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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.
ID · 59fd19f6-b8c6-4b49-b291-59e469dd4528