Sanofi Facility Attracts FDA Scrutiny Over Alleged High quality Lapses – Sanofi (NASDAQ:SNY)

The U.S. Meals and Drug Administration (FDA) issued a warning letter to Sanofi SA’s SNY Genzyme Company concerning vital violations at its Framingham, Massachusetts, facility.

After an inspection carried out between June 12 and July 9, 2024 the company flagged main issues concerning the facility’s processes for producing energetic pharmaceutical substances, or APIs.

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Inspection Findings

• FDA investigators documented a number of important points, together with a failure to adequately examine deviations, deal with manufacturing inconsistencies, and use correctly designed tools.
• Roughly 20% of bioreactor runs between January 2022 and July 2024 have been rejected as a result of contamination or different high quality failures, highlighting critical course of management deficiencies.
• Investigations into these incidents usually lacked thorough root trigger analyses, acceptable corrective actions, or satisfactory documentation.
• For instance, two numerous APIs have been discovered to include seen particles, however investigations failed to handle all contributing elements. Moreover, high-pressure product leakage occasions throughout manufacturing have been inadequately reviewed, and engineering research conclusions have been ignored.
• The FDA noted situations the place Genzyme deviated from validated manufacturing processes, growing the danger of microbial contamination.
• One notable deviation concerned the unauthorized substitution of producing parts, which was later linked to contamination occasions.
• The company additionally criticized utilizing unsuitable tools, together with cell carts and units with identified design flaws that might permit microbial ingress.

The ability’s high quality unit was additionally scrutinized for its incapacity to make sure compliance with present Good Manufacturing Practices requirements. As of June 2024, the standard unit had 84 open and overdue deviation investigations, some exceeding 180 days. FDA inspectors noticed unreported deviations, similar to improper aseptic practices and tools setup points.

The FDA additionally discovered Genzyme’s proposed corrective and preventive actions (CAPAs) inadequate.

Sanofi should reply inside 15 working days, outlining its corrective measures and supply the FDA with a timeline for completion.

Worth Motion: Sanofi inventory is down 0.91% at $51.22 eventually examine Wednesay.

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