Eurofins BioPharma Product Testing Sweden AB — FDA Facility Profile
Eurofins BioPharma Product Testing Sweden AB is an FDA-registered facility (FEI 3008763211) located in Uppsala, SE. Registered operations: ANALYSIS. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jun 19, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (4 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 19, 2024 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 8, 2022 | Voluntary Action Indicated (VAI) | No citations listed |
| May 12, 2017 | No Action Indicated (NAI) | No citations listed |
| Mar 13, 2015 | Voluntary Action Indicated (VAI) | Lab controls established, including changes (21 CFR 211.160(a)) Complete test data included in records (21 CFR 211.194(a)) Deviations from laboratory control requirements (21 CFR 211.160(a)) |
| Feb 18, 2011 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Defined areas of adequate size for operations (21 CFR 211.42(c)) Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Following/documenting laboratory controls (21 CFR 211.160(a)) and 2 more |
Facility details
- Company
- Eurofins BioPharma Product Testing Sweden AB
- Location
- Uppsala (SE)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS
- Source
- decrs