Fresenius Kabi AB — FDA Facility Profile
Fresenius Kabi AB is an FDA-registered facility (FEI 3002631703) located in Uppsala, SE. Registered operations: ANALYSIS; API MANUFACTURE; MANUFACTURE. RegDataLab tracks 9 FDA inspections at this facility.
Reviewing Fresenius Kabi AB 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 Fresenius Kabi AB 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
- Jan 24, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 9 (8 VAI, 1 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
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jan 24, 2025 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 21, 2023 | Voluntary Action Indicated (VAI) | No citations listed |
| Oct 15, 2020 | Voluntary Action Indicated (VAI) | No citations listed |
| Oct 16, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 7, 2017 | Voluntary Action Indicated (VAI) | Following/documenting laboratory controls (21 CFR 211.160(a)) |
| Mar 20, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 11, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 25, 2012 | No Action Indicated (NAI) | No citations listed |
| Sep 30, 2010 | Voluntary Action Indicated (VAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Cleaning/maintenance records not kept (21 CFR 211.67(c)) SOPs not followed / documented (21 CFR 211.100(b)) Approval and review of procedures (21 CFR 211.100(a)) and 1 more |
Facility details
- Company
- Fresenius Kabi AB
- Location
- Uppsala (SE)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; API MANUFACTURE; MANUFACTURE
- Source
- both