# FDA 483 - Eurofins PROXY Laboratories B.V. - September 07, 2017

Source: https://www.keypedia.com/records/483/eurofins-proxy-laboratories-bv/d7fc0f09-cfaa-4ba4-988f-bea088e0177f

> FDA 483 for Eurofins PROXY Laboratories B.V. on September 07, 2017. 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: 2017-09-07
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Eurofins MicroSafe Laboratories, a control testing laboratory in Leiden, Netherlands, revealed significant deficiencies. Observations included a failure to calibrate instruments at suitable intervals and a lack of thorough review for unexplained discrepancies, particularly regarding delayed investigations into action level excursions. These issues indicate potential concerns with quality control and data integrity.

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321