The Food and Drug Administration has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility in Massachusetts where the company makes ingredients used to produce various medicines.
In a Jan. 15 letter, the agency noted its inspectors found that 20% of bioreactor runs attempted between January 2022 and July 24 were rejected due to contamination or other quality control failures. A bioreactor is a vessel used to grow organisms and cells. The FDA called this an “excessive” rate and chided the company for failing to adequately investigate the problem.
The FDA, whose inspectors visited the Framingham, Mass., plant in June and July 2024, also scolded Sanofi for “multiple” instances in which the facility deviated from so-called good manufacturing processes, a regulatory term that refers to acceptable standards. In some instances, the problems were not addressed until FDA investigators informed Sanofi personnel.
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