483
Sanofi Pasteur LimitedFDA 483 - Sanofi Pasteur Limited
Record Details
Sanofi Pasteur Limited, a vaccines manufacturer in Toronto, Canada, was cited for significant deficiencies during an FDA inspection. Observations included inadequate investigations into vaccine component leaks, deficient environmental monitoring in aseptic processing, a failure to maintain backups for critical electronic data, and poor equipment maintenance leading to contamination risks. These issues indicate a systemic breakdown in quality control and data integrity practices.
- Company
- Sanofi Pasteur Limited
- Product Type
- Biologics
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ID · 78def083-c617-4f99-8dfc-0f30d9c2b53c