483
Janssen Pharmaceutica, N.V.Janssen Pharmaceutica, N.V. – FDA 483, Sep 5, 2025
Record Details
An FDA inspection of Janssen Pharmaceutica N.V., a biopharmaceutical facility in Beerse, Antwerpen, Belgium, revealed significant data integrity and reporting deficiencies. The firm failed to accurately convey all tested particle size distribution (PSD) samples and data, including rejected samples and incorrect values, in method validation and study reports. Additionally, not all in vitro release testing (IVRT) incidents and repeated tests were properly documented and conveyed in reports.
View Company Profile
ID · 6c8e1b3c-df77-49af-9a7b-08fc5cf52d66
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.