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

Source: https://www.keypedia.com/records/483/emergent-biosolutions-canada-inc/59362ced-5bf4-4a69-878d-f22fa01b1671

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

---

## Details

- Record Type: 483
- Company Name: Emergent BioSolutions Canada Inc.
- Inspection Date: 2026-06-12
- Product Type: biologics
- Office Name: FDA District Office — Rockville, Maryland
- Summary: An FDA inspection of Cangene Corporation in Winnipeg, Canada, revealed ten significant observations related to manufacturing controls, quality systems, and document management. Key issues included inadequate investigations into process interruptions, insufficient defect rate management, uncontrolled document usage, and deviations from written procedures, indicating a need for improved quality oversight.

## Related Documents

- [483 - 2025-08-27](https://www.keypedia.com/records/483/emergent-biosolutions-canada-inc/75506747-dd4b-4d84-81b6-12f978febec5)
- [483 - 2017-05-16](https://www.keypedia.com/records/483/emergent-biosolutions-canada-inc/eaad9354-0479-4352-94fc-d7c1d6593d19)
- [483 - 2022-05-10](https://www.keypedia.com/records/483/emergent-biosolutions-canada-inc/db1326a9-58e9-476c-b73d-08323f92c683)
- [EIR - 2017-05-16](https://www.keypedia.com/records/eir/emergent-biosolutions-canada-inc/7fa46f2c-136f-4c06-b745-db11b0880179)
- [EIR - 2019-09-13](https://www.keypedia.com/records/eir/emergent-biosolutions-canada-inc/0f36b00b-1ddb-4f8c-a960-feed8a7e48d4)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/fda-district-office-rockville-maryland/9fe39975-71c8-4e5b-96b6-5b06ccc261ec