# FDA 483 - Sanofi Winthrop Industrie - June 15, 2018

Source: https://www.keypedia.com/records/483/sanofi-winthrop-industrie/0f0611ea-c63b-402d-bd8b-2261c9b027e9

> FDA 483 for Sanofi Winthrop Industrie on June 15, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sanofi Winthrop Industrie
- Inspection Date: 2018-06-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sanofi Winthrop Industrie in Tours, France, was cited for failing to fully follow quality control unit responsibilities and procedures. Specifically, the firm did not revalidate a manufacturing process for a drug after making significant changes to parameters, equipment, and chemicals. This lapse resulted in the production of a batch for the US market using a non-validated process.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.keypedia.com/companies/sanofi-winthrop-industrie/88a4c8ee-d792-4747-acb7-de304d1efbb6

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1