Last Updated on February 10, 2025 by The Health Master
Warning letter
The U.S. Food and Drug Administration (USFDA) has issued a warning letter to Sanofi mentioning the deviations from Current Good Manufacturing Practice (CGMP) in Framingham, Massachusetts at its Genzyme Corporation facility.
Violations
The warning letter, issued on January 15, 2025, to Sanofi mentions the critical violations, which include:
Investigation of deviations:
The USFDA observed that the facility failed to properly investigate the critical deviations, e.g., in-process high-pressure events and microbiological contamination events, which may impact the safety and quality of drugs.
Deviations from validated manufacturing processes:
The facility was found to deviate from validated manufacturing procedures on multiple incidents, which may lead to compromising the safety and quality of its products.
Equipment found not suitable:
The facility was found utilizing unsuitable equipment that was not suitable for use in microbiologically controlled manufacturing environments, which is increasing the contamination risk.
Quality unit oversight:
The USFDA also observed that the quality unit of the facility is also lacking the authority and resources for effectively ensuring compliance with CGMP regulations.
Evaluate all production deviations:
Many deviations with respect to the production found went unaddressed when they were finally observed by the USFDA FDA inspectors, which indicates a lack of proper oversight and further adherence to established procedures in the facility.
The warning letter demands that Sanofi must take immediate corrective action to address these critical violations.
Noncompliance with these violations may result in serious consequences, which include seizure of drugs, injunctions, and withdrawal of marketing approvals for affected drugs.
Sanofi has 15 working days to reply to the USFDA’s warning letter with a detailed plan and procedures to address the violations.
To read the full contents of the warning letter, click here
Reference: Various warning letters issued by USFDA
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Note: This news article focuses on the key findings of the USFDA Warning Letter. It is crucial to refer to the official warning letter for complete and accurate information regarding the specific violations and required corrective actions.
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