FDA 483 - Janssen Pharmaceutica, N.V. - September 05, 2025

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.