483
Emergent BioSolutions Canada Inc.Emergent BioSolutions Canada Inc. – FDA 483, Sep 13, 2019
Record Details
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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ID · f84c9db4-128b-41d7-9e66-953bc5de12d6
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