# FDA 483 - Covance by Labcorp - May 20, 2021

Source: https://www.globalkeysolutions.net/records/483/covance-by-labcorp/7a6bfe64-9576-4295-abd3-9eee9a8b41af

> FDA 483 for Covance by Labcorp on May 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covance by Labcorp
- Inspection Date: 2021-05-20
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Covance by Labcorp in Durham, NC, a Contract Research Organization, revealed a failure to ensure proper monitoring of a clinical study. Approximately 100 protocol deviations, some deemed "important," were not identified in a timely manner. These issues impacted subject safety, regulatory compliance, and data integrity.

## Related Officers

- [Betsy C. Galliher](https://www.globalkeysolutions.net/people/betsy-c-galliher/04add63c-cbcb-42f7-b634-7c2925600bef)

Company: https://www.globalkeysolutions.net/companies/covance-by-labcorp/6294f9c8-cbf5-4d8e-b2dd-5b12ebea5cbf

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7