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Food and Drug Administration

Trashed tests put FDA on notice as China pushes drug exports

WASHINGTON _ During a visit to Zhejiang Hisun Pharmaceutical Co.'s factory in the Chinese city of Taizhou this year, FDA inspectors noticed a worrisome sign. When workers conducted quality tests on drugs for export to the United States they sometimes didn't record the results. Other times, they deleted them. It was a warning signal that led the Food and Drug Administration to ban 15 drug products from Hisun worth about $31 million, over concerns that the medicine might not meet U.S. quality standards. Hisun said it has addressed the problems. Policing drug manufacturers abroad has become a critical task for the FDA because medicine that doesn't meet U.S. standards could...