# FDA 483 - Janssen Biologics B.V. - September 21, 2026

Source: https://www.globalkeysolutions.net/records/483/janssen-biologics-bv/aaf8436c-365f-4ed0-8b0c-111c7a62a295

> FDA 483 for Janssen Biologics B.V. on September 21, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Biologics B.V.
- Inspection Date: 2026-09-21
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Janssen Biologics B.V. in Leiden, The Netherlands, was cited for significant issues during an FDA inspection related to its biological bulk drug substance manufacturing. The inspection revealed failures in preventing microbial and endotoxin contamination during production, with numerous out-of-specification events reported. Additionally, the Quality Unit failed to conduct complete investigations and implement timely corrective and preventive actions for these contamination issues.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/janssen-biologics-bv/548da985-9cd1-447d-9554-a699671301e8)

## Related Officers

- [Clinical Trials Associate](https://www.globalkeysolutions.net/people/rebeca-rodriguez/6dc44559-b1bf-44ac-95f3-af5fa8a4acd7)

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

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