FDA 483 - Eurofins PROXY Laboratories B.V. - November 10, 2023

Eurofins PROXY Laboratories B.V. in Leiden, Netherlands, was inspected and cited for significant deficiencies in its manufacturing of sterile drug products. The observations highlight inadequate validation of sterilization processes, poorly designed equipment for aseptic operations and cleaning, ineffective deviation investigations, and a failure to follow change control procedures and provide required GMP training. These issues indicate a serious lack of control over critical manufacturing processes and quality systems.