483
Emergent BioSolutions Canada Inc.FDA 483 - Emergent BioSolutions Canada Inc. - September 13, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
Open in Dashboard
ID · f84c9db4-128b-41d7-9e66-953bc5de12d6