Drugmaker Ignored More Than 200 Bad Quality Tests, FDA Says
- Fresenius plant in India makes ingredients for cancer drugs
- FDA sends warning letter, asks for ‘immediate’ assessment
The headquarters of Fresenius SE in Bad Homburg, Germany.
Photographer: Ulf Schneider/Bloomberg
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U.S. regulators warned Fresenius SE after the company’s Indian plant that makes cancer-drug ingredients for the U.S. market aborted hundreds of drug-quality tests because they seemed like they were going to fail due to impurities.
When workers at the plant found potential tainted products, they halted the tests and said human or machine errors were to blame instead, according to a Food and Drug Administration warning letter dated Dec. 4 that cited 248 aborted checks at the West Bengal facility.