FDA 483 - Janssen Vaccines, Zweigniederlassung der Cilag GmbH International - May 29, 2026
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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.
- Inspection Date
- May 29, 2026
- Product Type
- Biologics
ID · 3485ebe9-9893-453c-b357-5dfcffd6290e