# FDA 483 - SANOFI PASTEUR LIMITED - Unknown Date

Source: https://www.keypedia.com/records/483/sanofi-pasteur-limited/f12df0b3-e55e-488a-b03c-2075284d67a9

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Sanofi Pasteur Limited, a vaccines manufacturer in Toronto, Canada, was cited for significant deficiencies across its quality control and manufacturing operations. Observations included inadequate laboratory controls for product testing, insufficient in-process specifications, poor batch record review, and environmental monitoring failures in aseptic areas. Additionally, equipment suitability, manufacturing record control, facility maintenance, and test equipment calibration were found to be deficient, indicating systemic issues in ensuring product quality and safety.

## Related Officers

- [Diana Kouliavskaia, Research Biologist](https://www.keypedia.com/people/diana-kouliavskaia-research-biologist/32c98b0d-a26b-43a1-b9be-09e0adcc746b)
- [Cynthia Jha, CSO](https://www.keypedia.com/people/cynthia-jha-cso/65b65428-79da-4c40-8da0-be6116e95edf)
- [Paul Keller, Product Specialist](https://www.keypedia.com/people/paul-keller-product-specialist/be48b5bc-5574-49ce-8fca-bb1438c02f32)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.keypedia.com/companies/sanofi-pasteur-limited/759ad1ac-b1ba-48d2-bcd8-29c276944283

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd