483
Sanofi Pasteur LimitedFDA 483 - Sanofi Pasteur Limited - October 07, 2019
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Sanofi Pasteur Limited, a biologics manufacturer in Toronto, Canada, was cited for significant sanitary deficiencies during an FDA inspection. The inspection revealed multiple instances of insect presence in a Grade (b) (4) clean room area, indicating a failure to maintain sanitary conditions. These issues were exacerbated by ineffective corrective and preventive actions and inadequately sealed doors, posing a risk to product quality.
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ID · 913f5a80-a23a-47f2-b652-daee17f36a9b