FDA EIR - Charles River Laboratories, LLC - July 26, 2019

An FDA surveillance inspection of Charles River Laboratories Ashland, LLC, a biopharmaceutics analytical facility located in Skokie, IL, was conducted from July 22-26, 2019. This inspection, carried out under Compliance Program 7348.004 for In Vivo Bioavailability/Bioequivalence Studies, assessed two studies supporting drug evaluation. The facility operates as a contract research organization providing bioanalytical services. Key issues, documented in a Form FDA 483, included the firm's failure to incorporate all valid data from precision and accuracy testing into final statistical calculations, specifically excluding outliers without evidence of technical error. Additionally, the firm did not fully validate the precision and accuracy for certain dilution factors, yet these unvalidated factors were subsequently used to analyze study samples in a pharmacokinetic study. Discussions with management also covered deficiencies in method validation titer precision and an unassessed interference for a specific substance in the pharmacokinetic assay. Management acknowledged these observations and committed to providing a written response within 15 business days.