FDA 483 - Medpace Bioanalytical Laboratories

An FDA inspection of Medpace Bioanalytical Laboratories in Cincinnati, OH, revealed deficiencies in method validation practices. The firm failed to include all sample measurements in statistical determinations of accuracy and precision, did not adequately establish stability during method validation, and did not assess potential interferences from multiple metabolites/analytes. These issues indicate a lack of robust analytical method validation.