PAREXEL International GmbHAugust 18, 2016

FDA 483 - PAREXEL International GmbH - August 18, 2016

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Parexel International GmbH Early Phase Clinical Unit Berlin, a Contract Research Organization, was inspected by the FDA. The inspection revealed one observation concerning the firm's failure to retain reserve samples of test and reference articles used in in vivo bioequivalence studies. This indicates a lapse in adherence to regulatory requirements for sample management.

Company: PAREXEL International GmbH
Inspection Date: August 18, 2016
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Richard W. Berning (Bioresearch Monitoring Foreign Inspection Cadre Member)

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