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How to Avoid FDA Warning Letters

And how to not get to that point in the first place

Fotos/Unsplash

William A. Levinson
Tue, 06/17/2025 - 12:03
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According to the U.S. News & World Report article “FDA Warns Sanofi of Manufacturing Irregularities at Key Facility” (Jan. 23, 2025), the pharmaceutical company Sanofi received a U.S. Food and Drug Administration warning letter “stating that FDA inspectors found irregularities with the facility’s bioreactor, the vessel used to grow organisms and cells.” It adds that 20% of bioreactor runs were rejected due to contamination and other problems.

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