FDA 483 - Almac Sciences Limited - March 10, 2023

Almac Sciences Limited, a drug substance manufacturer in Craigavon, United Kingdom, was cited for two significant observations during an FDA inspection. The firm failed to adequately investigate unknown impurities in drug substance batches manufactured on-site, allowing undetected peaks to go uninvestigated. Additionally, the company lacked robust controls for its water system, resulting in persistent microbiological contamination with objectionable organisms.