# FDA 483 - BioConnection B.V. - March 04, 2024

Source: https://www.keypedia.com/records/483/bioconnection-bv/20a279ff-6d28-476a-8a26-91b64377573b

> FDA 483 for BioConnection B.V. on March 04, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioConnection B.V.
- Inspection Date: 2024-03-04
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of BioConnection in Oss Noord-Brabant, The Netherlands, identified two significant observations. The firm's microbial cross-contamination control was deemed inadequate due to improper handling practices during filling line operations. Additionally, the environmental and personnel monitoring techniques, specifically finger dab and surface contact plate sampling, were found to be insufficient.

## Related Documents

- [483 - 2018-06-01](https://www.keypedia.com/records/483/bioconnection-bv/4d7cd9ef-e01a-4455-88dd-5188e0f70483)
- [483 - 2020-03-04](https://www.keypedia.com/records/483/bioconnection-bv/e946c94a-fea4-4cc0-b56a-f953ff4de73e)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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