# FDA 483 - Janssen Biologics B.V. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/janssen-biologics-bv/548da985-9cd1-447d-9554-a699671301e8

> FDA 483 for Janssen Biologics B.V. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Biologics B.V.
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: During an inspection from July 7-11, 2014, Janssen Biologics B.V. in Leiden, Netherlands, a drug substance manufacturer, was cited for inadequate investigations into batch failures. The firm failed to extend investigations of microbiological contaminations in bioreactor assemblies to other associated batches or drug substances, indicating a significant lapse in their quality system.

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- [483 - 2026-09-21](https://www.globalkeysolutions.net/records/483/janssen-biologics-bv/aaf8436c-365f-4ed0-8b0c-111c7a62a295)

## Related Officers

- [Patric C. Klotzbuecher](https://www.globalkeysolutions.net/people/patric-c-klotzbuecher/cbb2e6b5-b001-457e-9073-33535f02926e)

Company: https://www.globalkeysolutions.net/companies/janssen-biologics-bv/2e04e15b-1d3c-493d-b2d0-dcbc2108639b

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