FDA Inspection
Emergent BioSolutions Canada Inc.Emergent BioSolutions Canada Inc. – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Emergent BioSolutions Canada Inc., with an inspection on September 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 64b5df63-13be-4816-aba5-ce48e1aeef78
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109095
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Emergent BioSolutions Canada Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2026 | Not classified | Office of Inspections and Investigations | Blood and Blood Products |
| August 27, 2025 | Not classified | Office of Inspections and Investigations | |
| May 16, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 3, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 18, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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