# FDA 483 - Eurofins Bactimm B.V. - October 13, 2023

Source: https://www.globalkeysolutions.net/records/483/eurofins-bactimm-bv/bc8d69ee-ef84-4893-b14e-996665497a9f

> FDA 483 for Eurofins Bactimm B.V. on October 13, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Eurofins Bactimm B.V.
- Inspection Date: 2023-10-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Eurofins Bactimm B.V., a contract microbiological testing laboratory in Nijmegen, Netherlands, identified a significant deficiency in laboratory controls. The firm's quality control unit failed to adequately validate analytical test methods to establish hold times for drug product sterility and endotoxin testing. This lapse indicates a potential risk to the assurance of identity, strength, quality, and purity of tested drug products.

## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.globalkeysolutions.net/companies/eurofins-bactimm-bv/4c302e15-8cf0-42b7-90d0-e2afa7cad298

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