# FDA 483 - Emergent BioSolutions Canada Inc. - May 10, 2022

Source: https://www.globalkeysolutions.net/records/483/emergent-biosolutions-canada-inc/0712f356-7635-47ec-bb53-1d16f00681a6

> FDA 483 for Emergent BioSolutions Canada Inc. on May 10, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emergent BioSolutions Canada Inc.
- Inspection Date: 2022-05-10
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Emergent BioSolutions Canada Inc. in Winnipeg, MB, revealed significant deficiencies in their manufacturing processes. The observations primarily concern inadequate procedures to prevent microbial contamination, issues with aseptic processing using a Vanrx system, and insufficient laboratory controls for samples. These findings indicate potential risks to product sterility and quality.

## Related Documents

- [483 - 2022-05-10](https://www.globalkeysolutions.net/records/483/emergent-biosolutions-canada-inc/397d94c4-3030-47bc-8dd8-39e2e6fa2f64)

## Related Officers

- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)
- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.globalkeysolutions.net/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)

Company: https://www.globalkeysolutions.net/companies/emergent-biosolutions-canada-inc/003b8611-6e96-4935-a98c-6a1d66d9e789

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd