FDA Inspection
Eurofins Chemical Analysis Pty LtdEurofins Chemical Analysis Pty Ltd – FDA Inspection, Mar 24, 2017
Record Details
This FDA Inspection record concerns Eurofins Chemical Analysis Pty Ltd, with an inspection on March 24, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 94ed3194-7e16-4cea-928e-932fa833942d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006999
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
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Other FDA inspections of Eurofins Chemical Analysis Pty Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 27, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Eurofins Chemical Analysis Pty Ltd
- FDA Inspection 1177970 - 2022-07-27
- FDA Inspection 891452 - 2014-06-27
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