# FDA 483 - Labcorp Early Development Laboratories, Inc. - August 19, 2010

Source: https://www.globalkeysolutions.net/records/483/labcorp-early-development-laboratories-inc/91789c52-258c-4c85-9112-166608070d93

> FDA 483 for Labcorp Early Development Laboratories, Inc. on August 19, 2010. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Labcorp Early Development Laboratories, Inc.
- Inspection Date: 2010-08-19
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Covance Laboratories Inc. in Madison, WI, a GLP laboratory, revealed significant deviations from standard operating procedures during a study. These deviations included unauthorized changes and inconsistent data reporting for bioanalytical determinations, as well as improper timing for in-life dose administrations. The findings indicate a failure to adhere to established protocols and proper documentation practices.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/scott-b-laufenberg/ff95c69f-5ee2-4761-b4ef-8b8137c3d963)

Company: https://www.globalkeysolutions.net/companies/labcorp-early-development-laboratories-inc/fd7a8136-483e-4368-bbf9-d12f2e2ca1f2

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