# FDA 483 - Sanofi Pasteur Limited - October 07, 2019

Source: https://www.globalkeysolutions.net/records/483/sanofi-pasteur-limited/913f5a80-a23a-47f2-b652-daee17f36a9b

> FDA 483 for Sanofi Pasteur Limited on October 07, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi Pasteur Limited
- Inspection Date: 2019-10-07
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

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## Related Officers

- [Anita Verma, Ph.D., Research Biologist](https://www.globalkeysolutions.net/people/anita-verma-phd-research-biologist/127c7da3-64ec-4d97-a3f4-a5844ff27fb6)
- [Leslie Wagner](https://www.globalkeysolutions.net/people/leslie-wagner/be24e214-ff08-43d8-9547-51ee27e6b4f2)
- [Danielle J. Leal, Chemist](https://www.globalkeysolutions.net/people/danielle-j-leal-chemist/4a42a6cd-cc44-4d35-b733-066d7a2e35f2)
- [Joan Johnson, CSO, Lead Investigator](https://www.globalkeysolutions.net/people/joan-johnson-cso-lead-investigator/408dcb85-fd6c-4050-a905-4b3ef9738018)

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

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