# FDA 483 - Labcorp Early Development Laboratories, Inc. - August 12, 2022

Source: https://www.keypedia.com/records/483/labcorp-early-development-laboratories-inc/013ec608-d669-452d-adb0-9b7b888f6def

> FDA 483 for Labcorp Early Development Laboratories, Inc. on August 12, 2022. 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: 2022-08-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Labcorp Drug Development in Greenfield, IN, a nonclinical laboratory, revealed multiple significant deficiencies. The firm failed to properly authorize and document deviations from standard operating procedures, exhibited inadequate quality assurance oversight, and lacked sufficient written procedures for various laboratory operations. Issues also included incomplete personnel training records, inaccurate master schedule entries, and insufficient control over test and control articles.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/lynda-lanning/3b6db3e1-32c7-4ff5-9c3f-c20635863535)
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Company: https://www.keypedia.com/companies/labcorp-early-development-laboratories-inc/e6487660-cd04-47c4-879b-cc0248eba943

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