FDA EIR - Charles River Laboratories, Inc. - September 09, 2025

An unannounced FDA inspection of Charles River Laboratories, Inc. in Wilmington, MA, was conducted from September 2-9, 2025. The inspection focused on the firm's In Vivo biosafety testing and procedures, operating under the regulatory framework of Compliance Program 7356.002 Drug Process Inspections, with its quality system adhering to 21 CFR Parts 210, 211, and 600. The primary observation, documented on a Form FDA 483, highlighted that written records of investigations into unexplained discrepancies did not consistently include comprehensive conclusions and follow-up. Specifically, an investigation into potential data integrity issues regarding temperature records failed to evaluate all of the implicated technician's cGMP activities. Additionally, a Corrective and Preventative Action (CAPA) related to test group mortalities due to bacterial contamination lacked documented preventative retraining for the responsible technician. Other concerns discussed included delayed approval of an equipment re-qualification report and apparent rouging on a biological safety cabinet. Charles River Laboratories management committed to submitting a written response to the Agency addressing the FDA 483 observations within 15 business days.