Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses

The U.S. Food and Drug Administration (FDA) issued a warning letter to Sanofi SA’s SNY Genzyme Corporation regarding significant violations at its Framingham, Massachusetts, facility.

After an inspection conducted between June 12 and July 9, 2024 the agency flagged major concerns about the facility’s processes for producing active pharmaceutical ingredients, or APIs.

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Inspection Findings

• FDA investigators documented several critical issues, including a failure to adequately investigate deviations, address manufacturing inconsistencies, and use properly designed equipment.
• Approximately 20% of bioreactor runs between January 2022 and July 2024 were rejected due to contamination or other quality failures, highlighting serious process control deficiencies.
• Investigations into these incidents often lacked thorough root cause analyses, appropriate corrective actions, or adequate documentation.
• For example, two lots of APIs were found to contain visible particles, but investigations failed to address all contributing factors. Additionally, high-pressure product leakage events during manufacturing were inadequately reviewed, and engineering study conclusions were ignored.
• The FDA noted instances where Genzyme deviated from validated manufacturing processes, increasing the risk of microbial contamination.
• One notable deviation involved the unauthorized substitution of manufacturing components, which was later linked to contamination events.
• The agency also criticized using unsuitable equipment, including mobile carts and devices with known design flaws that could allow microbial ingress.

The facility’s quality unit was also scrutinized for its inability to ensure compliance with current Good Manufacturing Practices standards. As of June 2024, the quality unit had 84 open and overdue deviation investigations, some exceeding 180 days. FDA inspectors observed unreported deviations, such as improper aseptic practices and equipment setup issues.

The FDA also found Genzyme’s proposed corrective and preventive actions (CAPAs) insufficient.

Sanofi must respond within 15 working days, outlining its corrective measures and provide the FDA with a timeline for completion.

Price Action: Sanofi stock is down 0.91% at $51.22 at last check Wednesay.

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