FDA 483 - Charles River Laboratories, Inc. DBA Charles River, Endosafe - September 09, 2025

During an FDA inspection conducted from September 2 to September 9, 2025, an unnamed firm, with Megan Dodge serving as Director of Operations, received an FDA Form 483 detailing significant observations regarding their quality system. The primary concern highlighted was the incomplete nature of written records for investigations into unexplained discrepancies, specifically lacking comprehensive conclusions and follow-up actions, which is critical under Current Good Manufacturing Practices (CGMP).

Key issues included Deviation 2076279, which involved potential data integrity problems related to temperature records. While an investigation confirmed a technician did not perform study-related work, there was no documented evaluation of this technician's other CGMP activities. Additionally, CAPA 2057840, initiated due to high animal mortalities during in vivo testing and attributed to technician-induced bacterial contamination, lacked documented preventative actions, such as retraining, despite successful re-testing.

These observations indicate a need for the firm to enhance its adherence to regulatory frameworks by ensuring thorough investigations are conducted, robust corrective and preventive actions are implemented, and all necessary documentation is maintained to prevent recurrence and ensure product quality and safety. The firm is expected to address these deficiencies with corrective measures.