# FDA 483 - Emergent BioSolutions Canada Inc. - September 13, 2109

Source: https://www.keypedia.com/records/483/emergent-biosolutions-canada-inc/f84c9db4-128b-41d7-9e66-953bc5de12d6

> FDA 483 for Emergent BioSolutions Canada Inc. on September 13, 2109. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emergent BioSolutions Canada Inc.
- Inspection Date: 2109-09-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Emergent BioSolutions Canada Inc. in Winnipeg, MB, Canada, a contract manufacturer of sterile human drugs, revealed a critical lapse in contamination prevention. Specifically, procedures designed to prevent microbiological contamination of sterile drug products were not followed during equipment setup. This indicates a potential risk to product sterility.

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## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1