FDA Inspection
Eurofins BioPharma Product Testing Sweden ABEurofins BioPharma Product Testing Sweden AB – FDA Inspection, Feb 18, 2011
Record Details
This FDA Inspection record concerns Eurofins BioPharma Product Testing Sweden AB, with an inspection on February 18, 2011, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- February 18, 2011
- Product Type
- Veterinary
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ID · 3bc23b41-8917-4135-9efe-a98f59f54687
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 725048
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
6- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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Other FDA inspections of Eurofins BioPharma Product Testing Sweden AB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 12, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Eurofins BioPharma Product Testing Sweden AB
- FDA Inspection 1233031 - 2022-12-08
- FDA Inspection 1016317 - 2017-05-12
- FDA Inspection 920666 - 2015-03-13
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