# FDA 483 - Sanofi S.r.l. - May 22, 2023

Source: https://www.keypedia.com/records/483/sanofi-srl/ef6db67d-39bd-408f-9d63-88d1a0226efe

> FDA 483 for Sanofi S.r.l. on May 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi S.r.l.
- Inspection Date: 2023-05-22
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: During an inspection from May 12-22, 2023, Sanofi S.p.A in Anagni, Italy, was cited for significant deficiencies in its aseptic processing procedures and aseptic process simulations. The firm failed to establish and follow procedures to prevent microbiological contamination of sterile drug products and conducted simulations that did not fully represent actual manufacturing conditions. These issues indicate a risk to the sterility and quality of drug products.

## Related Documents

- [483 - 2023-02-02](https://www.keypedia.com/records/483/sanofi-srl/4b220987-179f-49af-987e-cfdcfa19741a)
- [483 - 2023-05-22](https://www.keypedia.com/records/483/sanofi-srl/2279210a-e1bd-440f-986a-4fcd7039ee8d)

## Related Officers

- [Richard Ledwidge](https://www.keypedia.com/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.keypedia.com/companies/sanofi-srl/54ba861a-36eb-4486-a4ba-2a8194cdf7a5

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