FDA Inspection
Carbogen Amcis B.V.Carbogen Amcis B.V. – FDA Inspection, Nov 16, 2018
Record Details
This FDA Inspection record concerns Carbogen Amcis B.V., with an inspection on November 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 49660153-9cf0-4703-a05b-d2759e0b0b7a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074000
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Carbogen Amcis B.V.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 28, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 27, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Carbogen Amcis B.V.
- FDA Inspection 1280210 - 2022-11-09
- FDA Inspection 911610 - 2015-01-28
- FDA Inspection 755264 - 2011-10-27
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