FDA Inspection
Emergent BioSolutions Canada Inc.Emergent BioSolutions Canada Inc. – FDA Inspection, Feb 3, 2015
Record Details
This FDA Inspection record concerns Emergent BioSolutions Canada Inc., with an inspection on February 3, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 3, 2015
- Product Type
- Drugs
View Company Profile
ID · a919edeb-836c-4b0c-8464-a43471aac8c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918929
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.113(b)Validation lacking for sterile drug products
Full citation text and observation details available on the Dashboard.
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 | |
| 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 |
| July 18, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Emergent BioSolutions Canada Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.