# FDA 483 - PAREXEL International GmbH - August 18, 2016

Source: https://www.keypedia.com/records/483/parexel-international-gmbh/e2269a1a-7331-4b90-a92f-e1d4f48e332e

> FDA 483 for PAREXEL International GmbH on August 18, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PAREXEL International GmbH
- Inspection Date: 2016-08-18
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Bioresearch Monitoring Foreign Inspection Cadre Member](https://www.keypedia.com/people/richard-w-berning/4637e321-8803-4fcf-911f-bbc810c3487d)

Company: https://www.keypedia.com/companies/parexel-international-gmbh/9fec3e79-26fc-4af5-9210-226e0624a7e2

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd