FDA EIR - Charles River Laboratories Inc - August 29, 2018

An FDA surveillance inspection of Charles River Laboratories Inc. in Frederick, MD, was conducted from August 27 to August 29, 2018. This Prescription Drug User Fee Act (PDUFA) inspection, guided by FDA protocols for non-clinical laboratories and OSIS directives, focused on the facility's histopathology and archiving services. The inspection covered two Investigational New Drug (IND) numbers, for which the Frederick site provided histopathology readings of slides processed at their Reno, NV, facility. Investigators reviewed study records, Standard Operating Procedures (SOPs), correspondence, and electronic data capture (EDC) source records, including the Provantis database system. A thorough assessment of the firm's organization, personnel training, facilities, equipment maintenance, and Quality Assurance Unit procedures was performed. Notably, the inspection concluded with no FDA-483 being issued, indicating an absence of significant objectionable conditions or violations. Management received no adverse observations during the close-out meeting, and no specific regulatory actions were required from Charles River Laboratories Inc.