FDA 483 - Charles River Laboratories Inc - October 17, 2025

From October 13 to 17, 2025, the FDA conducted an inspection of the Charles River Laboratories, Inc. manufacturing facility in Memphis, Tennessee. The resulting Form 483 details a primary regulatory concern regarding the company"s failure to maintain accurate and updated Standard Operating Procedures (SOPs) and training documents. Inspectors observed that numerous procedures for equipment cleaning, maintenance, and manufacturing training did not reflect current operations. Specific issues included SOPs referencing outdated equipment sanitization steps, decommissioned computerized systems, and invalid document numbers for biohazardous waste disposal. Furthermore, there were significant discrepancies between the document numbers recorded in the firm’s electronic system and the physical forms used on the manufacturing floor. These observations were issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act. Although this report is not a final determination of compliance, Charles River Laboratories is required to address these administrative and operational gaps. The company must submit a formal response to the FDA detailing its corrective action plan to ensure all documentation accurately aligns with current equipment and safety protocols.