FDA EIR - Charles River Laboratories Inc - April 03, 2019

An FDA surveillance inspection of Charles River Laboratories Inc. in Horsham, PA, was conducted from March 25 to April 3, 2019. This Prescription Drug User Fee Act (PDUFA) inspection specifically targeted the company's nonclinical laboratory operations, adhering to Good Laboratory Practice (GLP) regulations as outlined in Compliance Program 7348.808 and overseen by the Center for Biologics Evaluation and Research (CBER).

The inspection encompassed a thorough review of three animal research studies, examining protocols, raw data, and final reports. Auditors also assessed the firm's organizational structure, personnel qualifications, quality assurance systems, facility maintenance, equipment calibration, and adherence to Standard Operating Procedures. Interactions with various staff members and observations of animal care demonstrations were integral to the review.

Significantly, the inspection concluded without identifying any objectionable conditions or main findings. No FDA Form 483, which details observations of potential regulatory violations, was issued. Therefore, Charles River Laboratories Inc. received a "no action indicated" classification, confirming compliance with the regulatory framework and requiring no specific remedial actions from the company. This positive outcome is consistent with their previous inspection classification.