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

Source: https://www.globalkeysolutions.net/records/483/janssen-pharmaceutica-nv/6c8e1b3c-df77-49af-9a7b-08fc5cf52d66

> FDA 483 for Janssen Pharmaceutica, N.V. on September 05, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Pharmaceutica, N.V.
- Inspection Date: 2025-09-05
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ruben-c-ayala/6b5dadad-56b8-4af0-a65f-4685f71f0c8d)
- [Xingfang Li](https://www.globalkeysolutions.net/people/xingfang-li/ba1d0660-b34d-4acf-bd63-e5c7c9c2f8cb)

Company: https://www.globalkeysolutions.net/companies/janssen-pharmaceutica-nv/7ed39763-06a4-46b7-a9a1-76399c53844c

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8