Eurofins Lancaster Laboratories, Inc – FDA 483, Aug 26, 2025

An FDA inspection conducted at Eurofins Lancaster Laboratories, LLC, a contract testing laboratory located in Lancaster, PA, from August 20-26, 2025, resulted in the issuance of a Form FDA 483. The inspection highlighted two significant observations related to the firm's quality control and laboratory practices, indicating potential non-compliance with Good Manufacturing Practices as per Section 704(b) of the Federal Food, Drug and Cosmetic Act. The first observation concerned inadequate procedures for microbial limits testing. Specifically, the process for handling culture media bottles used in bioburden testing was found insufficient to prevent the thermal destruction of viable microorganisms. The written procedure lacked critical controls, such as documented verifications of elapsed cooling time and temperature of the media prior to use, as well as controls for adding new media to the cooling bath. This deficiency could compromise the accuracy and reliability of microbial testing results for drug products. The second observation identified shortcomings in the investigation of unexplained discrepancies. The firm's records of investigations into microorganism recovery during sterility testing were incomplete, particularly regarding root cause determination. It was noted that integrity testing for gloves used during sterility testing was not performed prior to their replacement, preventing the identification of potential contamination sources from glove failures. To address these findings, Eurofins Lancaster Laboratories, LLC is expected to implement comprehensive corrective actions, including revising testing procedures to ensure microbial viability and enhancing investigation protocols to thoroughly identify root causes of contamination, thereby ensuring the integrity and safety of tested drug products.