# FDA 483 - Sanofi Pasteur Limited - March 18, 2025

Source: https://www.keypedia.com/records/483/sanofi-pasteur-limited/dbff4f5b-209a-4042-a06c-c9ca18935fd1

> FDA 483 for Sanofi Pasteur Limited on March 18, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi Pasteur Limited
- Inspection Date: 2025-03-18
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Sanofi Pasteur Limited in North York, Ontario, a vaccine manufacturer, identified a critical issue with their bioburden sample collection process. The design of this process consistently leads to leaking and spilling of materials in a controlled environment. This observation highlights significant concerns regarding quality control and the potential for contamination in the manufacturing of sterile products.

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## Related Officers

- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)
- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8