483
Janssen Vaccines, Zweigniederlassung der Cilag GmbH InternationalJanssen Vaccines, Zweigniederlassung der Cilag GmbH International – FDA 483, May 29, 2026
Record Details
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
View Company Profile
ID · 3485ebe9-9893-453c-b357-5dfcffd6290e
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.