FDA 483 - Eurofins PROXY Laboratories B.V. - September 07, 2017

An FDA inspection of Eurofins MicroSafe Laboratories, a control testing laboratory in Leiden, Netherlands, revealed significant deficiencies. Observations included a failure to calibrate instruments at suitable intervals and a lack of thorough review for unexplained discrepancies, particularly regarding delayed investigations into action level excursions. These issues indicate potential concerns with quality control and data integrity.