FDA EIR - Charles River Laboratories, Inc. - August 07, 2008

An FDA inspection of Charles River Laboratories, Inc., located in Frederick, MD, was conducted from August 4 to August 7, 2008. This inspection was a Good Laboratory Practice (GLP) surveillance assignment, adhering to 21 CFR Part 58 and Compliance Program 7348.808, which outline GLP for nonclinical laboratories. The inspection team thoroughly reviewed the company's operations, procedures, and three specific studies, examining various records including standard operating procedures, training documentation, equipment logs, and study data. Notably, no formal "Inspectional Observations" (FDA 483) were issued at the conclusion of this inspection, nor during a prior inspection in 2006. However, four items were discussed with management during the 2008 inspection. These included issues related to documenting the storage location of test articles for immunopathology studies prior to 2008, ensuring management review of facility inspections, and minor errors in a master schedule test article name and a final report's study material location. Charles River Laboratories provided a response addressing these discussion points, and management was reminded of their ongoing commitment to GLP regulations. The inspection concluded with a preliminary classification of "No Action Indicated" (NAI), pending final classification, indicating that no significant non-compliance or formal corrective actions were mandated.