# FDA 483 - Labcorp Early Development Laboratories, Inc. - May 07, 2025

Source: https://www.keypedia.com/records/483/labcorp-early-development-laboratories-inc/e3f7df59-2ddc-4102-877c-824da6204939

> FDA 483 for Labcorp Early Development Laboratories, Inc. on May 07, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Labcorp Early Development Laboratories, Inc.
- Inspection Date: 2025-05-07
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Labcorp Early Development Laboratories, Inc. in Madison, WI, received a Form 483 for a significant Good Laboratory Practice (GLP) violation. The inspection revealed that the study director failed to ensure the proper transfer of all raw data, documentation, and reports to the archives at the close of a study. This included a failure to perform required Quality Control (QC) review on immunology and immunotoxicity data before its submission to the archival unit.

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## Related Officers

- [Carmen Y. Fisher](https://www.keypedia.com/people/carmen-y-fisher/d41b9f1a-1a29-4b1c-bd64-acedde50302a)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8