FDA 483 - Eurofins SF Analytical Laboratories, Inc. - June 03, 2026

Eurofins SF Analytical Laboratories, Inc. in Horsham, PA, was inspected and found to have significant deficiencies in laboratory controls and data integrity. Observations included failures to investigate out-of-specification results and compromised microbial plates, incomplete laboratory records, and inadequate computer system controls. These issues indicate a lack of scientifically sound test procedures and proper data review, potentially impacting product quality and patient safety.