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

An FDA inspection of Charles River Laboratories, Inc. in Wilmington, MA, a contract testing laboratory, revealed a significant issue with the firm's investigation records. Specifically, written records for unexplained discrepancies did not consistently include complete conclusions and follow-up actions. This indicates a potential weakness in the firm's quality system regarding thoroughness of investigations and preventative measures.