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# Emergent BioSolutions EIR and FDA-483
- URL: https://www.fdaweb.com/emergent-biosolutions-eir-and-fda-483/
- Published: 2022-01-27T12:00:00.000Z
- Updated: 2026-09-14T17:30:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151021

FDA has just released an Establishment Inspection Report (EIR) from a 9/5/2019-9/13/2019 inspection at Emergent BioSolutions Canada, Winnipeg, Manitoba, and an FDA-483 with one inspection observation from that inspection. The company is a contract manufacturer of sterile human drugs.

The one observation on the [FDA-483](http://www.fda.gov/media/155673/download?ref=fdaweb.com) was that procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. Read the EIR [here](http://www.fda.gov/media/155667/download?ref=fdaweb.com).