# FDA 483 - Sanofi Winthrop Industrie - November 17, 2023

Source: https://www.keypedia.com/records/483/sanofi-winthrop-industrie/927847f9-6cd0-4a6d-9e66-dd953b28c35a

> FDA 483 for Sanofi Winthrop Industrie on November 17, 2023. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi Winthrop Industrie
- Inspection Date: 2023-11-17
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: The FDA conducted an inspection of Sanofi Winthrop Industrie, a biologic drug substance manufacturer located in Lyon, France, from November 9 to November 17, 2023. The inspection revealed several critical observations regarding compliance issues.

Key violations identified include inadequate laboratory investigations, particularly concerning Thymoglobulin drug product testing, where a high rate of test result invalidations was noted without thorough investigation or corrective actions. Additionally, equipment cleaning procedures were found lacking, with no established or monitored cleaning intervals. The facility also failed to implement adequate corrective and preventive actions (CAPAs) for action limit excursions related to microbial contamination in the Thymoglobulin manufacturing area. Furthermore, there were no records to demonstrate the decontamination of equipment and utensils over the past three years, despite existing standard operating procedures outlining necessary decontamination steps.

The FDA's observations highlight significant gaps in Sanofi Winthrop Industrie's compliance with regulatory standards, particularly in ensuring product quality and safety. The firm is required to address these issues by implementing thorough investigations, corrective actions, and preventive measures to prevent recurrence. Additionally, they must establish and document effective equipment cleaning and decontamination processes to maintain compliance and ensure the integrity of their manufacturing operations.

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Company: https://www.keypedia.com/companies/sanofi-winthrop-industrie/f7668868-7954-441c-b8bf-ab135e8645c2

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d