FDA Faults China’s Hisun Pharmaceutical

Abstract

FDA has released a warning letter it issued to Zhejiang Hisun Pharmaceutical, a major Chinese drug supplier. In September, FDA had banned from the U.S. most active pharmaceutical ingredients made at Hisun’s Taizhou facility. In the letter, FDA details numerous instances of data manipulation and deletions. “Our investigators found that your firm routinely re-tested samples without justification and deleted analytical data,” the letter says. Hisun staff also impeded FDA officials’ work, according to the letter. For instance, a Hisun employee took off with a thumb drive when an inspector ordered him to hand it over during an inspection in March. FDA notes that its “concerns about deletion of data are heightened by the significant number of customer complaints for subpotency and out-of-specification impurity levels from 2012 to 2014.”