FDA 483 - Eurofins Lancaster Laboratories, Inc - May 30, 2025

Eurofins Lancaster Laboratories, Inc. in Portage, MI, a contract testing laboratory, was cited for significant deficiencies across its quality control and laboratory operations. The inspection revealed issues with inadequate investigations into discrepancies and out-of-specification results, poor data integrity controls for electronic systems, and scientifically unsound test procedures. Additionally, the firm failed to follow established procedures and maintain adequately qualified stability chambers, indicating systemic problems in ensuring drug product quality and purity.