# FDA 483 - Covance Clinical Research Unit, Inc. - June 07, 2019

Source: https://www.globalkeysolutions.net/records/483/covance-clinical-research-unit-inc/ed4f092c-473c-484d-8f53-c820699e49f3

> FDA 483 for Covance Clinical Research Unit, Inc. on June 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covance Clinical Research Unit, Inc.
- Inspection Date: 2019-06-07
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Covance Clinical Research Unit, Inc. in Dallas, TX, revealed a significant issue with record retention. The firm failed to maintain individual blinding codes for a clinical trial for the required two-year period, destroying them prematurely. This indicates a serious lapse in regulatory compliance regarding document control for clinical investigations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/travis-m-beard/a89f6d0b-dc5b-4adc-84f5-36e04b00fc2d)
- [Andrace Deyampert](https://www.globalkeysolutions.net/people/andrace-deyampert/cdb4f833-488b-42b9-abab-4216435bce4c)

Company: https://www.globalkeysolutions.net/companies/covance-clinical-research-unit-inc/77031e78-7971-49cf-9572-8fe510634538

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9