# FDA 483 - Labcorp Early Development Laboratories, Inc. - July 12, 2024

Source: https://www.globalkeysolutions.net/records/483/labcorp-early-development-laboratories-inc/a453ffad-c6bd-464d-a825-36d29ecaf0d4

> FDA 483 for Labcorp Early Development Laboratories, Inc. on July 12, 2024. 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: 2024-07-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Labcorp Early Development Laboratories, Inc. in Greenfield, IN, was cited with three observations during an FDA inspection of its nonclinical laboratories. The inspection revealed significant issues with Good Laboratory Practice, including the study director's failure to ensure timely archiving of study materials and the quality assurance unit's failure to maintain an accurate master schedule. Additionally, final study reports omitted the names of all involved scientists, and two of the observations were repeats from a previous inspection, indicating persistent non-compliance.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)
- [investigator](https://www.globalkeysolutions.net/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

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

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0