# FDA 483 - Sanofi Winthrop Industrie - July 17, 2018

Source: https://www.globalkeysolutions.net/records/483/sanofi-winthrop-industrie/9a199ad5-eec6-4a64-913a-0d8bd40cde2e

> FDA 483 for Sanofi Winthrop Industrie on July 17, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi Winthrop Industrie
- Inspection Date: 2018-07-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Sanofi Chimie' in Aramon, France, a drug substance manufacturer, was cited for significant issues during an FDA inspection. Observations included inadequate process validation controls leading to numerous Out-of-Specification results, analytical methods that were not accurate or reproducible, and a failure to timely close out investigations. These issues indicate a severity related to fundamental quality system and manufacturing process control deficiencies.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.globalkeysolutions.net/companies/sanofi-winthrop-industrie/a9432693-ea49-48d8-941a-a91408c0acc4

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