FDA Inspection
Eurofins Biopharma Product Testing, Denmark A/SEurofins Biopharma Product Testing, Denmark A/S – FDA Inspection, Jun 22, 2016
Record Details
This FDA Inspection record concerns Eurofins Biopharma Product Testing, Denmark A/S, with an inspection on June 22, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 22, 2016
- Product Type
- Drugs
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ID · aef8fe15-3be8-45e4-b1ad-0b861b1efd96
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 976102
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 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
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Other FDA inspections of Eurofins Biopharma Product Testing, Denmark A/S
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 30, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 12, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Eurofins Biopharma Product Testing, Denmark A/S
- FDA Inspection 1222906 - 2023-05-17
- FDA Inspection 811362 - 2012-12-14
- FDA Inspection 780431 - 2012-03-30
- FDA Inspection 578807 - 2009-05-12
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