# FDA 483 - BioConnection B.V. - June 01, 2018

Source: https://www.keypedia.com/records/483/bioconnection-bv/4d7cd9ef-e01a-4455-88dd-5188e0f70483

> FDA 483 for BioConnection B.V. on June 01, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BioConnection B.V.
- Inspection Date: 2018-06-01
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Bio Connection B.V. in Oss, Netherlands, revealed significant deficiencies in quality control and manufacturing processes. The firm was cited for inadequate validation of bioburden testing, failure to reject non-conforming components, and insufficient growth promotion studies. Additionally, the inspection found unreported manufacturing changes and the distribution of an unapproved product to the U.S. market, indicating a moderate level of non-compliance.

## Related Documents

- [483 - 2020-03-04](https://www.keypedia.com/records/483/bioconnection-bv/e946c94a-fea4-4cc0-b56a-f953ff4de73e)
- [483 - 2024-03-04](https://www.keypedia.com/records/483/bioconnection-bv/20a279ff-6d28-476a-8a26-91b64377573b)

## Related Officers

- [investigator](https://www.keypedia.com/people/ewa-marszal/99a58182-3534-4af8-a64d-e463b2f60226)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.keypedia.com/companies/bioconnection-bv/b119ef65-94a1-4beb-9c2a-940c44e6c06e

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd