Novartis Manufacturing NV — FDA Facility Profile
Novartis Manufacturing NV is an FDA-registered facility (FEI 3002037047) located in Puurs-Sint-Amands Antwerpen, BE. Registered operations: LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.
Reviewing Novartis Manufacturing NV as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Novartis Manufacturing NV yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
What FDA found at this site
- Latest inspection
- Mar 5, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (4 VAI, 2 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
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 5, 2025 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 29, 2021 | Voluntary Action Indicated (VAI) | No citations listed |
| Nov 9, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Nov 15, 2016 | Voluntary Action Indicated (VAI) | Procedures for sterile drug products (21 CFR 211.113(b)) Investigations of discrepancies, failures (21 CFR 211.192) Complete test data included in records (21 CFR 211.194(a)) |
| Mar 26, 2014 | No Action Indicated (NAI) | No citations listed |
| Jan 29, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Novartis Manufacturing NV
- Location
- Puurs-Sint-Amands Antwerpen (BE)
- Registration Expires
- Dec 31, 2027
- Operations
- LABEL; MANUFACTURE; PACK
- Source
- both