# FDA 483 - Eurofins PROXY Laboratories B.V. - September 19, 2025

Source: https://www.keypedia.com/records/483/eurofins-proxy-laboratories-bv/4af7ca66-83d1-41ef-8b0f-d8d7aa19ed79

> FDA 483 for Eurofins PROXY Laboratories B.V. on September 19, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins PROXY Laboratories B.V.
- Inspection Date: 2025-09-19
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: Eurofins PROXY Laboratories B.V., a contract testing organization in Leiden, Netherlands, was inspected and cited for significant deficiencies across its quality control unit, laboratory operations, and procedural controls. Observations included untimely closure of deviations, inadequate investigation of out-of-specification results, and deficient written procedures for handling non-conformances. Additionally, the firm's cleanrooms used for sterility testing had an inadequate air pressure monitoring system, indicating a lack of robust quality systems and controls.

## Related Documents

- [483 - 2014-11-06](https://www.keypedia.com/records/483/eurofins-proxy-laboratories-bv/56905317-dd87-4565-8f8f-965fdf229b8b)
- [EIR - 2016-09-16](https://www.keypedia.com/records/eir/eurofins-proxy-laboratories-bv/b7adc238-01e4-41b6-9bd3-5e8d0bd7a7a9)
- [483 - 2017-09-07](https://www.keypedia.com/records/483/eurofins-proxy-laboratories-bv/d7fc0f09-cfaa-4ba4-988f-bea088e0177f)

## Related Officers

- [investigator](https://www.keypedia.com/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)
- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)

Company: https://www.keypedia.com/companies/eurofins-proxy-laboratories-bv/2efa7b51-ca37-4d11-aa86-bb3a7d987ca7

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8