483
PAREXEL International GmbHPAREXEL International GmbH – FDA 483, Aug 18, 2016
Record Details
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.
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ID · e2269a1a-7331-4b90-a92f-e1d4f48e332e
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