> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Amended Sanofi Warning Letter
- URL: https://www.fdaweb.com/amended-sanofi-warning-letter/
- Published: 2025-01-21T12:00:00.000Z
- Updated: 2026-09-14T14:51:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158514

FDA has issued an amended Warning Letter to Sanofi, replacing the 12/16/2024 letter addressing significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs) found in a 6/12-7/9/2024 inspection at the firm’s Genzyme Corp. subsidiary in Framingham, MA. The amended [letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sanofi-690604-01152025?ref=fdaweb.com) says the specific Genzyme deviations were:

- failure to investigate all critical deviations;
- failure to demonstrate that the manufacturing process can reproducibly manufacture APIs meeting predetermined quality attributes;
- failure to have equipment of the appropriate design and suitability for their intended use to manufacture APIs;
- failure of the firm’s quality unit to exercise its responsibility to ensure the APIs manufactured at the facility comply with CGMP; and
- failure to ensure all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions recorded.

The letter says that its significant findings indicate that the firm’s quality unit is not able to fully exercise its authority and/or responsibilities. “Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality,” it says.

Genzyme was told to correct deviations promptly and to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.