FDA 483 - Charles River Laboratories, LLC - July 26, 2019

An FDA inspection of Charles River Laboratories Ashland, LLC in Skokie, IL, a biopharmaceutics analytical facility, revealed two significant observations. The firm failed to include all valid data in statistical calculations for precision, accuracy, and total error during method validation. Additionally, the inspection found that the firm did not fully validate the precision and accuracy of certain dilution factors used in a study.