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

Source: https://www.keypedia.com/records/483/emergent-biosolutions-canada-inc/a5330eb6-cd14-45e1-b45f-c51436ec1117

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

---

## Details

- Record Type: 483
- Company Name: Emergent BioSolutions Canada Inc.
- Inspection Date: 2026-05-12
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of Emergent BioSolutions Canada Inc. in Winnipeg revealed significant deficiencies in quality control, data integrity, and manufacturing processes. Observations included failures in sample handling, investigation of product discrepancies, change control, equipment qualification and maintenance, and employee training. These issues indicate a systemic lack of adherence to established procedures and controls for biologics drug manufacturing.

## 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

- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)
- [investigator](https://www.keypedia.com/people/yonggang-wang/5c7dd00f-f810-4f86-9c78-51ae7f4b8acd)

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

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917