Sanofi Pasteur Limited – FDA 483, Oct 7, 2019

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.