# FDA 483 - Labcorp Early Development Laboratories, Inc. - August 20, 2018

Source: https://www.keypedia.com/records/483/labcorp-early-development-laboratories-inc/dcb14db6-9461-4aa1-940c-bb6808c34574

> FDA 483 for Labcorp Early Development Laboratories, Inc. on August 20, 2018. 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: 2018-08-20
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Covance Laboratories, Inc. in Madison, WI, from August 20-24, 2018, revealed a significant issue with data integrity and quality control. The firm failed to adhere to its established criteria for run acceptance, specifically by accepting and then unjustifiably rejecting chromatographic results during method validation. This indicates a breakdown in laboratory control procedures.

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## Related Officers

- [Bioresearch Monitoring Specialis](https://www.keypedia.com/people/denise-l-burosh/075a442f-67e0-4a65-9c09-e8819a329773)
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Company: https://www.keypedia.com/companies/labcorp-early-development-laboratories-inc/fd7a8136-483e-4368-bbf9-d12f2e2ca1f2

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