# FDA 483 - Janssen Vaccines, Zweigniederlassung der Cilag GmbH International - May 29, 2026

Source: https://www.keypedia.com/records/483/janssen-vaccines-zweigniederlassung-der-cilag-gmbh-international/3485ebe9-9893-453c-b357-5dfcffd6290e

> FDA 483 for Janssen Vaccines, Zweigniederlassung der Cilag GmbH International on May 29, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Vaccines, Zweigniederlassung der Cilag GmbH International
- Inspection Date: 2026-05-29
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: Janssen Vaccines, a biological drug substance manufacturer in Bern, Switzerland, was cited for incomplete and insufficient investigations into out-of-specification (OOS) results. The firm failed to adequately assess the product impact of OOS findings across multiple batches, including those distributed to the U.S. market, and did not determine a root cause for the discrepancies. This indicates a significant concern regarding quality control and product release procedures.

## Related Officers

- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.keypedia.com/companies/janssen-vaccines-zweigniederlassung-der-cilag-gmbh-international/f1be536a-aa34-43b6-afde-568c99db0c81

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917