483
Emergent BioSolutions Canada Inc.Emergent BioSolutions Canada Inc. – FDA 483, May 12, 2026
Record Details
An FDA inspection of Emergent BioSolutions Canada Inc. in Winnipeg revealed significant deficiencies in quality control, data integrity, and manufacturing processes. Observations included failures in sample handling, investigation of product discrepancies, change control, equipment qualification and maintenance, and employee training. These issues indicate a systemic lack of adherence to established procedures and controls for biologics drug manufacturing.
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ID · a5330eb6-cd14-45e1-b45f-c51436ec1117
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