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

An FDA inspection of Charles River Laboratories, Inc. in Reno, NV, a nonclinical laboratory, revealed significant deficiencies in their study documentation and reporting practices. The firm failed to accurately record experimental data, ensure protocols contained all necessary details, and include complete descriptions of methods and test systems in final study reports. These issues suggest a lack of adherence to Good Laboratory Practice regulations.