# Sanofi Winthrop Industrie – FDA 483, Jun 15, 2018

Source: https://www.keypedia.com/records/483/sanofi-winthrop-industrie/bc069d2e-844a-4ab0-99be-5d6ddefbf69c

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

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## Details

- Record Type: 483
- Company Name: Sanofi Winthrop Industrie
- Inspection Date: 2018-06-15
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: During an inspection, 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 product after significant changes, leading to the production of batches for the US market using a non-validated process. This indicates a significant lapse in quality assurance and process control.

## 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-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3