FDA EIR - Charles River Laboratories Inc - June 02, 2022

An unannounced, directed surveillance inspection of Charles River Laboratories Inc. in Spencerville, OH, was conducted by the FDA from May 31, 2022, to June 2, 2022. The inspection, performed under Compliance Program 7348.808 for Good Laboratory Practice (Nonclinical Laboratories), focused on a specific study's final report due to a complaint from the study sponsor. The main issue verified was a significant discrepancy between the final study report archived by Charles River Laboratories and a different version submitted to the FDA by the study sponsor. The sponsor-submitted report contained numerous errors, including references to a recovery group that was explicitly removed from the study protocol, incorrect animal counts, inconsistent data time points, and various formatting and typographical issues. Charles River Laboratories had previously notified the FDA of these discrepancies in 2020. Importantly, the inspection found no objectionable conditions or practices at Charles River Laboratories, and no FDA Form 483 (Inspectional Observations) was issued. A minor recommendation was made regarding the use of waterproof pens for cage cards, which the company immediately addressed.