# FDA 483 - Eurofins Donor & Product Testing, Inc. Atlanta - November 05, 2024

Source: https://www.keypedia.com/records/483/eurofins-donor-product-testing-inc-atlanta/15d754e4-4fdb-4778-8a3f-53ae27227514

> FDA 483 for Eurofins Donor & Product Testing, Inc. Atlanta on November 05, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins Donor & Product Testing, Inc. Atlanta
- Inspection Date: 2024-11-05
- Product Type: other
- Office Name: Atlanta District Office
- Summary: Eurofins Donor & Product Testing, Inc. in Marietta, GA, was cited with two observations during an FDA inspection from October 29 to November 5, 2024. The firm failed to follow proper equipment calibration procedures, using incorrect specifications and incorrectly marking results as passing. Additionally, corrective actions for core Current Good Tissue Practice (CGTP) requirements were found to be inadequate, lacking verification of effectiveness and comprehensive short-term and long-term measures.

## Related Officers

- [Jannet M. Peroti](https://www.keypedia.com/people/jannet-m-peroti/204a2444-ae5c-42dc-b4a3-f2024db3368e)
- [Steven D. Banks](https://www.keypedia.com/people/steven-d-banks/30e4d016-e386-423d-9df8-1536cf43a0a3)
- [investigator](https://www.keypedia.com/people/leslie-w-gilbert/5c8b9e87-9563-4403-89ad-cfa3282a1ba5)

Company: https://www.keypedia.com/companies/eurofins-donor-product-testing-inc-atlanta/83fcf25f-19a4-4fe5-8cd5-c444c5e6b943

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7