# FDA 483 - Sanofi Pasteur Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/sanofi-pasteur-limited/78def083-c617-4f99-8dfc-0f30d9c2b53c

> FDA 483 for Sanofi Pasteur Limited on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi Pasteur Limited
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: 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.

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## Related Officers

- [Eric Peng](https://www.globalkeysolutions.net/people/eric-peng/d70b820f-7b9e-4cc9-9015-6ad92576a5a9)
- [Leslie Wagner](https://www.globalkeysolutions.net/people/leslie-wagner/be24e214-ff08-43d8-9547-51ee27e6b4f2)
- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)
- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)

Company: https://www.globalkeysolutions.net/companies/sanofi-pasteur-limited/5ee33067-6f94-437d-ace9-11581937a058

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321