FDA EIR - Charles River Laboratories Inc - September 21, 2020

An FDA inspection of Charles River Laboratories Inc. in Spencerville, OH, occurred from September 21 to October 1, 2020. This unannounced, critical Good Laboratory Practice (GLP) inspection focused on two nonclinical studies supporting a New Drug Application. While no formal FDA Form 483 was issued, the inspection identified several deviations and facility observations requiring attention. Key issues included protocol deviations in two studies (CMX001-NCA-106 and CMX001-NCA-123). For study 106, the final report omitted cell count data for Day 3, and several mice were underweight at dosing initiation, contrary to protocol. For study 123, some rabbits exceeded the required weight range, and bioanalytical sample collection times deviated from the protocol by varying minutes. General facility observations noted inadequate recordkeeping, with paper records in the archive not stored in protective bags. Personnel issues included one employee not changing gloves between handling control and test articles, and two not wearing required personal protective equipment. Equipment maintenance was also a concern, specifically a "filthy" bedding dispenser lacking cleaning records. Furthermore, multiple animal cages and a cage rack lacked proper sanitization cards, and non-functioning ceiling lights were observed in the clean cage storage area. Although a formal 483 was not issued, management committed to addressing the discussed items within 15 business days, and some SOP revisions were made during the inspection. The sponsor was notified of the data omission for study 106, with intent to inform the FDA.