# FDA 483 - Emergent BioSolutions Canada Inc. - June 12, 2026

Source: https://www.globalkeysolutions.net/records/483/emergent-biosolutions-canada-inc/1cbfaf63-4a96-443f-baf9-d05674d61023

> FDA 483 for Emergent BioSolutions Canada Inc. on June 12, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emergent BioSolutions Canada Inc.
- Inspection Date: 2026-06-12
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: Cangene Corporation in Winnipeg, MB, Canada, was inspected by the FDA, revealing significant deficiencies in manufacturing process investigations, quality control, document management, and adherence to written procedures. The inspection highlighted issues such as inadequate investigations into process interruptions, insufficient reject rate establishment for defects, and uncontrolled critical documents, indicating a lack of robust quality systems. These findings suggest potential risks to product quality and compliance with regulatory standards.

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## Related Officers

- [company_representative](https://www.globalkeysolutions.net/people/robert-fischer/438e55c1-71ee-4006-9794-10543e56bba6)
- [investigator](https://www.globalkeysolutions.net/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)
- [Senior Consultant](https://www.globalkeysolutions.net/people/paula-trost/638dc98a-6df6-4ce6-96ba-24f8749c3153)

Company: https://www.globalkeysolutions.net/companies/emergent-biosolutions-canada-inc/b307e34c-3470-4633-86ab-237341dae46c

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4