FDA Inspection
Emergent BioSolutions Canada Inc.Emergent BioSolutions Canada Inc. – FDA Inspection, May 12, 2026
Record Details
This FDA Inspection record concerns Emergent BioSolutions Canada Inc., with an inspection on May 12, 2026, issued by the Office of Inspections and Investigations, covering biologics.
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ID · 17acd2f3-4a76-4450-84f2-4575f2e7f499
Inspection Facts
- Inspection number
- 1316698
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Emergent BioSolutions Canada Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2025 | Not classified | Office of Inspections and Investigations | |
| September 13, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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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