Janssen Biologics B.V. — FDA Facility Profile
Janssen Biologics B.V. is an FDA-registered facility (FEI 3002806632) located in Leiden, NL. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 7 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jun 1, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (4 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 9
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 1, 2023 | Voluntary Action Indicated (VAI) | No citations listed |
| Oct 11, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 15, 2018 | No Action Indicated (NAI) | No citations listed |
| May 27, 2016 | No Action Indicated (NAI) | No citations listed |
| Jul 11, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 28, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 6, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Janssen Biologics B.V.
- Location
- Leiden (NL)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; API MANUFACTURE
- Source
- decrs