Drug factory · FDA FEI 3003153579
Emergent BioSolutions Canada Inc
155 Innovation Drive, Winnipeg, Canada
Problems found, fixed voluntarily at FDA's last inspection, Sep 13, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2011: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Anthrax Immune Globulin Human | Makes it | Emergent BioSolutions Canada Inc. | 60492-0249 |
| Botulism Antitoxin Heptavalent | Makes it, tests it and packages it | Emergent BioSolutions Canada Inc. | 60492-0075 |
| Human Vaccinia Virus Immune Globulin | Makes it and tests it | Emergent BioSolutions Canada Inc. | 60492-0173 |
| Raxibacumab | Makes it and tests it | Emergent BioDefense Operations Lansing LLC | 71655-103 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 3, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Oct 19, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 3, 2015 inspection
- Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Registered with FDA for: analysis; label; manufacture; pack.