FDA 483 - Eurofins Bactimm B.V. - October 13, 2023

An FDA inspection of Eurofins Bactimm B.V., a contract microbiological testing laboratory in Nijmegen, Netherlands, identified a significant deficiency in laboratory controls. The firm's quality control unit failed to adequately validate analytical test methods to establish hold times for drug product sterility and endotoxin testing. This lapse indicates a potential risk to the assurance of identity, strength, quality, and purity of tested drug products.