FDA Inspection
Eurofins Dr. Specht International GmbHEurofins Dr. Specht International GmbH – FDA Inspection, Feb 2, 2018
Record Details
This FDA Inspection record concerns Eurofins Dr. Specht International GmbH, with an inspection on February 2, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2e7ad322-15a7-41a1-a994-90f9f0aa76a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039985
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Eurofins Dr. Specht International GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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