Eurofins SF Analytical Laboratories, Inc. – FDA Warning Letter, Jun 3, 2026

The FDA issued a Warning Letter to Eurofins SF Analytical Laboratories, Inc. following an inspection of its Horsham, Pennsylvania facility conducted from June 1 to 3, 2026. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, which led the FDA to classify the tested drug products as adulterated under the Federal Food, Drug, and Cosmetic Act. The core issues involve systemic failures in laboratory data integrity and quality oversight. Specifically, analysts failed to record complete test results, selectively omitting data when microbial growth was too high to count. The laboratory also utilized compromised and desiccated testing media, which cannot reliably support microbial growth, and lacked a secondary verification process to ensure zero-colony counts were accurate. Furthermore, the firm failed to conduct thorough investigations into these discrepancies, often relying on subjective staff interviews rather than objective evidence. The Quality Unit was found to have insufficient authority and oversight to ensure compliance with safety standards. To remediate these issues, the FDA requires the company to hire an independent consultant to conduct a comprehensive audit of its operations. Eurofins must submit a detailed plan to improve documentation practices, including the implementation of digital, time-stamped photography for laboratory results. The firm is also required to provide an assessment of its investigation systems and a plan to empower its Quality Unit with the necessary resources and authority to maintain a state of control.