# FDA 483 - Eurofins PROXY Laboratories B.V. - November 10, 2023

Source: https://www.keypedia.com/records/483/eurofins-proxy-laboratories-bv/bfb8e0de-09f4-4e03-83ff-5f9f164ae505

> FDA 483 for Eurofins PROXY Laboratories B.V. on November 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins PROXY Laboratories B.V.
- Inspection Date: 2023-11-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Eurofins PROXY Laboratories B.V. in Leiden, Netherlands, was inspected and cited for significant deficiencies in its manufacturing of sterile drug products. The observations highlight inadequate validation of sterilization processes, poorly designed equipment for aseptic operations and cleaning, ineffective deviation investigations, and a failure to follow change control procedures and provide required GMP training. These issues indicate a serious lack of control over critical manufacturing processes and quality systems.

## Related Officers

- [Investigator](https://www.keypedia.com/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.keypedia.com/companies/eurofins-proxy-laboratories-bv/f285c14e-3524-4cb3-8bd8-767736fdfa78

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1