This isn't exactly a specific recall but I didn't know that we, as a country, were relying on manufacturers of drugs in China to produce vital lifesaving drugs/medications for American consumers.
FDA Cites Two Chinese Heparin MakersWASHINGTON -- Two Chinese-based firms shipped contaminated heparin to the U.S. between 2007 and 2008 and one company lied to federal health regulators about their role in the matter, according to the Food and Drug Administration.
The contaminated heparin, a widely used blood thinner, didn't reach any patients because the FDA stopped all the shipments at the border, according to FDA spokespeople.
Qingdao Jiulong Biopharmaceuticals Co. and Shanghai No. 1 Biochemical & Pharmaceutical Co. were involved in making and sending 19 lots of adulterated heparin sodium to the U.S., which the FDA discovered in April 2008.
"Although your firm quarantined some of the contaminated material apparently produced by Qingdao Jiulong in 2008, you permitted at least 19 lots to be shipped to the U.S.," said warning letters sent by the FDA on Tuesday. The letters mention that the companies have in the past supplied heparin to a California firm, Amphastar Pharmaceuticals Inc., and its subsidiary International Medication Systems Ltd. Amphastar did not return calls seeking comment.
This is the first public disclosure that the two Chinese firms were involved in the heparin affair, which started in late 2007 when federal regulators began receiving reports of allergic reactions and deaths in U.S. patients who had been given heparin.
The FDA lots of heparin were contaminated with over-sulfated chondroitin sulfate. The agency inspected the plants in July and August 2008 and, with respect to Shanghai No. 1 Biochemical, "uncovered untrue statements and information by your firm to the agency" relating to the actual maker of heparin. The agency determined that the blood thinner was made at two other plants, Qingdao Kangyuan or Qingdao Jiulong, and were relabeled and shipped.
The FDA told the Chinese suppliers that the agency can refuse to grant new drug applications or allow shipments to unload.
Congress has strongly criticized the agency's handling of the matter and said the agency doesn't conduct enough foreign inspections. Indeed, FDA statistics show the FDA conducted 947 foreign inspections in fiscal year 2008, compared with 1,003 in fiscal 2007, an all-time high for the agency.
The FDA has begun opening offices in China and India, and plans on having four permanent inspectors in China by the middle of the summer.
In a congressional hearing in March 2008, the FDA said contaminated heparin was linked to 12 plants in China but refused to name all but Changzhou SPL, considered the main supplier.
Amphastar, which had about $61 million in sales in 2007, makes pre-filled syringes and other products. The FDA told the Chinese suppliers that the agency can refuse to grant new drug applications or allow shipments to unload.
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