# FDA 483 - Labcorp Early Development Laboratories, Inc. - April 11, 2025

Source: https://www.globalkeysolutions.net/records/483/labcorp-early-development-laboratories-inc/a0c6dcc4-13b3-491f-b63f-857cdcb5a19e

> FDA 483 for Labcorp Early Development Laboratories, Inc. on April 11, 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: 2025-04-11
- Product Type: other
- Office Name: Detroit District Office
- Summary: An FDA inspection of Labcorp Early Development Laboratories, Inc. in Greenfield, IN, a nonclinical laboratory, revealed significant deficiencies in Good Laboratory Practices. Observations included failures in accurately recording experimental data, inadequate equipment inspection and maintenance, and a lack of established standard operating procedures for handling test and control articles. These issues indicate potential systemic problems in ensuring data integrity and operational quality.

## Related Documents

- [483 - 2022-08-12](https://www.globalkeysolutions.net/records/483/labcorp-early-development-laboratories-inc/013ec608-d669-452d-adb0-9b7b888f6def)
- [483 - 2024-07-12](https://www.globalkeysolutions.net/records/483/labcorp-early-development-laboratories-inc/a453ffad-c6bd-464d-a825-36d29ecaf0d4)
- [483 - 2025-07-25](https://www.globalkeysolutions.net/records/483/labcorp-early-development-laboratories-inc/0dbb8738-1977-47ac-b144-882ea229c9e8)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/corrine-m-carter/69e1be8c-1cd9-48d9-a08e-bf49060b94d6)
- [investigator](https://www.globalkeysolutions.net/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)

Company: https://www.globalkeysolutions.net/companies/labcorp-early-development-laboratories-inc/e6487660-cd04-47c4-879b-cc0248eba943

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03
