# FDA 483 - Emergent BioSolutions Canada Inc. - August 27, 2025

Source: https://www.globalkeysolutions.net/records/483/emergent-biosolutions-canada-inc/75506747-dd4b-4d84-81b6-12f978febec5

> FDA 483 for Emergent BioSolutions Canada Inc. on August 27, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Emergent BioSolutions Canada Inc.
- Inspection Date: 2025-08-27
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Emergent BioSolutions Canada Inc. in Winnipeg, MB, from August 19-27, 2025, revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. The firm lacked adequate operator monitoring, sterile gowning, cleaning protocols, and environmental controls in critical manufacturing areas, increasing the risk of product contamination.

## Related Documents

- [483 - 2026-06-12](https://www.globalkeysolutions.net/records/483/emergent-biosolutions-canada-inc/1cbfaf63-4a96-443f-baf9-d05674d61023)
- [483 - 2014-07-18](https://www.globalkeysolutions.net/records/483/emergent-biosolutions-canada-inc/b82b9b70-5da7-4766-874a-f0d400f4d797)
- [483 - 2017-05-16](https://www.globalkeysolutions.net/records/483/emergent-biosolutions-canada-inc/eaad9354-0479-4352-94fc-d7c1d6593d19)
- [483 - 2019-09-13](https://www.globalkeysolutions.net/records/483/emergent-biosolutions-canada-inc/913ba24d-ee0d-45bc-8462-3b51c8711772)
- [483 - 2109-09-13](https://www.globalkeysolutions.net/records/483/emergent-biosolutions-canada-inc/f84c9db4-128b-41d7-9e66-953bc5de12d6)

## Related Officers

- [Laurimer Kuilan-Torres](https://www.globalkeysolutions.net/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8