FDA 483 - Charles River Laboratories, Inc. DBA Charles River, Endosafe - March 27, 2026

During an inspection from March 23 to March 27, 2026, the FDA identified several quality control deficiencies at Charles River Laboratories, Inc. (DBA Charles River, Endosafe) in Charleston, South Carolina. As a contract testing laboratory, the facility is required to adhere to the Federal Food, Drug, and Cosmetic Act. The primary concerns centered on the quality unit"s failure to maintain oversight and follow established procedures. Investigators found that the lab failed to isolate testing areas from nearby construction, leading to dust accumulation in spaces used for endotoxin sample preparation. Additionally, the firm used uncalibrated equipment for sample weighing after the calibration due date had passed. The inspection also revealed that the laboratory misclassified a temperature storage deviation as minor rather than major and lacked formal procedures for documenting and investigating customer complaints regarding testing services. Furthermore, the laboratory"s methods for investigating invalid test results were deemed insufficient to identify long-term trends for products tested infrequently. These observations represent preliminary findings and not a final compliance determination. Charles River Laboratories is expected to respond to the FDA with a corrective action plan or discuss objections to these findings to ensure future compliance with regulatory expectations.