Novartis Pharma Stein AG — FDA Facility Profile
Novartis Pharma Stein AG is an FDA-registered facility (FEI 3002653483) located in CH-4332, CH. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 12 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 19, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 12 (8 VAI, 4 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 |
|---|---|---|
| May 19, 2026 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Procedures for sterile drug products (21 CFR 211.113(b)) |
| Jul 19, 2024 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 6, 2022 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 4, 2018 | Voluntary Action Indicated (VAI) | SOPs not followed / documented (21 CFR 211.100(b)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Buildings not maintained in good state of repair (21 CFR 211.58) |
| May 9, 2017 | Voluntary Action Indicated (VAI) | Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Procedures for sterile drug products (21 CFR 211.113(b)) Lot or control number assigned (21 CFR 211.130(c)) Quarantine Storage of Components (21 CFR 211.82(b)) and 4 more |
| Oct 16, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| May 1, 2015 | No Action Indicated (NAI) | No citations listed |
| Mar 25, 2014 | No Action Indicated (NAI) | No citations listed |
| Jun 22, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 2, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Novartis Pharma Stein AG
- Location
- CH-4332 (CH)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
- Source
- decrs