FDA EIR - Charles River Laboratories Inc - February 15, 2018

An FDA surveillance inspection of Charles River Laboratories Inc. in Horsham, PA, was conducted from February 6 to February 15, 2018. This inspection, carried out under the Prescription Drug User Fee Act (PDUFA) and in accordance with Compliance Program 7348.808, focused on the company's nonclinical laboratory operations, specifically animal research studies in developmental and reproductive toxicology, juvenile toxicology, neurobehavioral toxicology, phototoxicology, and cellular therapeutic safety. The regulatory framework guiding this review included Good Laboratory Practice (GLP) standards. The inspection involved a comprehensive review of three completed nonclinical studies, comparing protocols, raw data, and records to final reports. Additionally, the FDA assessed the firm’s organization, personnel, quality assurance unit, facilities, equipment, standard operating procedures, testing facility operations, and animal care practices. Crucially, the inspection identified no main violations or discrepancies across any of the reviewed areas, including personnel training, facility management, equipment calibration, computer systems, quality assurance processes, and animal welfare. Consequently, no Form FDA 483 was issued at the conclusion of the inspection, indicating a satisfactory outcome. There were no immediate required actions or discussion items addressed by the FDA, signifying full compliance with applicable regulations during this period.