# FDA 483 - Sanofi S.r.l. - February 02, 2023

Source: https://www.keypedia.com/records/483/sanofi-srl/4b220987-179f-49af-987e-cfdcfa19741a

> FDA 483 for Sanofi S.r.l. on February 02, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi S.r.l.
- Inspection Date: 2023-02-02
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Sanofi S.r.l., a medical device manufacturer in Anagni, Italy, received two observations during an FDA inspection. The firm was cited for inadequate procedures regarding corrective and preventive actions, specifically concerning root cause investigations and risk assessment for proposed actions. Additionally, the inspection found deficiencies in the firm's complaint handling system, including a failure to maintain records of adverse event complaints and an incomplete complaint handling procedure.

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## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

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