FDA 483 - Charles River Laboratories Inc. - March 15, 2024

An FDA inspection of Charles River Laboratories Inc. in Horsham, PA, a nonclinical laboratory, revealed deficiencies in their study reporting and oversight. The firm failed to include adequate descriptions of methods and environmental conditions in final study reports. Additionally, the study director did not ensure that unforeseen circumstances, such as temperature deviations, were properly noted, corrected, and documented, nor was their impact assessed.