- Although Zhejiang Hisun Pharmaceutical Co. has been subject to a strict import ban since September 2015, the U.S. is making an exception for the company to ship daunorubicin, a chemotherapy drug used to treat Kaposi's sarcoma.
- The FDA also sent Hisun a warning letter detailing numerous quality concerns three months after imposing the import ban. The letter cited violations such as manipulation of data, out-of-specification impurity levels between 2012 and 2014, and deformed culture plates.
- To date, Zhejiang has not properly addressed the deficiencies. However, in light of a potential shortage of the chemo drug, the FDA has exempted it from the still standing import ban.
When the U.S. issued the import ban on Zhejiang Hisun Pharmaceutical Co, the agency explicitly requested Hisun take measures to enhance quality oversight for its products, or else it would not be permitted to export to the U.S.
Though the import ban has been lifted temporarily, there is a potential for supply shortages.Two other firms manufacture the drug but it has run short before. Teva says it still has supply, while Bedford Labs says the product is unavailable, according to RAPS.
Nonetheless, the FDA will still need to ensure the incoming supply does not have any defects. Currently 42 Chinese drug manufacturers are on the FDA's "detention without physical examination of drugs" import ban.