# FDA 483 - Labcorp Clinical Research Unit, Inc. - October 07, 2022

Source: https://www.globalkeysolutions.net/records/483/labcorp-clinical-research-unit-inc/60aaa680-02b0-4c34-8a1b-8c895ef49045

> FDA 483 for Labcorp Clinical Research Unit, Inc. on October 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Labcorp Clinical Research Unit, Inc.
- Inspection Date: 2022-10-07
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Covance Cru Inc in Madison, WI, was cited for failing to conduct investigations in accordance with the signed statement of investigator and investigational plan during a bioequivalence study. Specifically, the firm did not report an identified autoinjector device defect, a black particle, to the sponsor as required by the study protocol and sponsor agreement. This indicates a deviation from established procedures for handling product complaints.

## Related Officers

- [Bioresearch Monitoring Specialis](https://www.globalkeysolutions.net/people/denise-l-burosh/075a442f-67e0-4a65-9c09-e8819a329773)
- [investigator](https://www.globalkeysolutions.net/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

Company: https://www.globalkeysolutions.net/companies/labcorp-clinical-research-unit-inc/d2860b46-6899-4e60-9c84-74b3d13b88cb

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d