FDA 483 - Charles River Laboratories, Inc. DBA Charles River, Endosafe - March 21, 2025

Charles River Laboratories, Inc., a nonclinical laboratory in Reno, NV, was inspected by the FDA from March 17 to March 21, 2025. This inspection resulted in an FDA Form 483, outlining significant observations regarding the conduct and reporting of nonclinical studies, indicating areas needing improvement in adherence to regulatory standards for data integrity and documentation. The primary issues identified include the study director's failure to ensure all experimental data, such as details for blood collection materials, dosing methods, and injection site markings, were accurately recorded and verified. Additionally, some study protocols lacked complete details regarding dosage levels, administration methods, and frequency for test articles. Final study reports were also found to be deficient, as they did not consistently include comprehensive descriptions of the analytical methods used for study samples, animal identification procedures, or the precise source of animals utilized in studies. These observations highlight the need for the firm to implement thorough corrective and preventive actions to ensure full compliance with regulatory requirements for nonclinical laboratory practices.