FDA Inspection
Eurofins Biopharma Product Testing Sweden ABEurofins Biopharma Product Testing Sweden AB – FDA Inspection, Feb 16, 2011
Record Details
This FDA Inspection record concerns Eurofins Biopharma Product Testing Sweden AB, with an inspection on February 16, 2011, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- February 16, 2011
- Product Type
- Veterinary
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ID · aded8721-b5a2-45d0-b79a-336deb4ccda5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 725045
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
FDA Citations
6- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(b)Written sanitation procedures not followed
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Other FDA inspections of Eurofins Biopharma Product Testing Sweden AB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 27, 2019 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 9, 2015 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Eurofins Biopharma Product Testing Sweden AB
- FDA Inspection 1273937 - 2024-06-19
- FDA Inspection 1096830 - 2019-06-27
- FDA Inspection 920664 - 2015-03-09
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