# FDA 483 - EUROFINS ANIMAL HEALTH TESTING - November 08, 2024

Source: https://www.globalkeysolutions.net/records/483/eurofins-animal-health-testing/6908284f-0d44-45ed-a290-38b94c607b26

> FDA 483 for EUROFINS ANIMAL HEALTH TESTING on November 08, 2024. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EUROFINS ANIMAL HEALTH TESTING
- Inspection Date: 2024-11-08
- Product Type: veterinary
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Eurofins Animal Health Testing in Indianapolis, IN, a nonclinical laboratory, was cited for significant deficiencies in its quality assurance unit and adherence to study protocols. The inspection revealed failures in documenting deviations from approved procedures, conducting studies according to protocol, and maintaining complete master schedule sheets for nonclinical laboratory studies. These issues indicate a lack of robust quality system oversight and control over critical study processes.

## Related Documents

- [483 - 2024-11-08](https://www.globalkeysolutions.net/records/483/eurofins-animal-health-testing/2c339bfe-d57d-4a9b-b26b-e3b3e7f69c73)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)

Company: https://www.globalkeysolutions.net/companies/eurofins-animal-health-testing/09445f10-2bee-452a-8219-38632f4990c4

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