FDA EIR - Parexel International - April 24, 2015

An FDA inspection of Parexel International's Glendale, CA facility, identified by FEI 3008736994, took place from April 21 to April 24, 2015. This comprehensive assessment was specifically conducted as a bioequivalence clinical study site inspection, adhering to the CPGM 7348.001 regulatory framework for "In Vivo Bioequivalence." The inspection primarily evaluated the conduct of two studies, (b) (4) and (b) (4), with Dr. Esther Yoon serving as the Principal Investigator for both. The inspection encompassed a wide range of operational areas critical to clinical research. These included the procedures for subject screening and enrollment, the integrity of specimen handling and laboratory processing, the management of electronic and paper records, adherence to study protocols, meticulous maintenance of subjects' records, proper informed consent processes, and oversight by the Institutional Review Board (IRB). Furthermore, the accountability and storage of test articles were also thoroughly reviewed. Crucially, the FDA investigator noted "no objectionable conditions" throughout the inspection. As a direct result, an FDA-483 (Inspectional Observations) was not issued to Parexel International at the conclusion of the review. This favorable outcome signifies that the firm was found to be operating in compliance with the relevant regulatory standards for conducting bioequivalence studies, requiring no specific corrective actions or enforcement measures from the FDA following this inspection.