FDA EIR - Charles River Laboratories Montreal ULC - July 31, 2009

An FDA inspection of Charles River Laboratories in Senneville, Canada, conducted from July 27-31, 2009, identified significant issues in their laboratory testing practices. This high-priority inspection, performed under the Sponsors, Contract Research Organizations and Monitors Compliance Program, focused on evaluating the firm's testing for a specific clinical study. Key violations included the failure to ensure method validation final reports were reviewed and approved before sample testing, and that draft validation reports for certain tests lacked adequate management or Quality Assurance review, containing errors. Analytical procedures for potency and another specific test were not updated and approved prior to implementing changes in testing parameters. For immunology testing, the critical cut-off value for interpreting results was established after sample analysis, leading to data re-assessment and changes in two subject results. The inspection also found a lack of documented test-specific training for analysts and insufficient record-keeping for sample movements within the immunology lab's storage freezer. Management acknowledged these observations, indicating that corrective actions would be determined after further review. The firm did provide a written response post-inspection and had already implemented a new sample management procedure since the study's testing period. No formal inspectional observations (FD-483) were issued.