Swedish Orphan Biovitrum AB (Publ) — FDA Facility Profile
Swedish Orphan Biovitrum AB (Publ) is an FDA-inspected facility (FEI 3003455777) located in Stockholm, SE. RegDataLab tracks 7 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Aug 29, 2019: No Action Indicated (NAI)
- Inspections on record
- 7 (5 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
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 29, 2019 | No Action Indicated (NAI) | No citations listed |
| May 4, 2018 | Voluntary Action Indicated (VAI) | Procedures to be written and followed (21 CFR 211.198(a)) |
| Mar 22, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| May 1, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 22, 2013 | No Action Indicated (NAI) | No citations listed |
| Jan 27, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Jan 20, 2009 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Swedish Orphan Biovitrum AB (Publ)
- Location
- Stockholm (SE)
- Source
- inspections