The FDA just cited two Chinese-based drug suppliers, Qingdao Jiulong Biopharmaceuticals Co. and Shanghai No. 1 Biochemical & Pharmaceutical Co, who manufactured and sold at least 19 lots of contaminated heparin to the U.S. in 2008, despite the fact that the heparin was supposed to be quarantined. (See 04/18/09 Wall Street Journal Article, “FDA Cites Two Chinese Heparin Makers.”) To read the FDA’s letter to Qingdao click here. To read the FDA’s letter to Shanghai No. 1 click here.

The heparin was tainted with over-sulfated chondroitin sulfate (“OSCS”), the same contaminate that has been linked with numerous U.S. deaths.

During the FDA’s inspection of these companies, the FDA found “significant deviations from U.S. current good manufacturing practices (CGMP) requirements in the manufacture of drugs.” Further, one of the drug suppliers, Shanghai No. I Biochemical, was also was found to have lied to the FDA about the manufacture of its heparin. Specifically, the FDA found that the Chinese drug supplier “used two other manufacturers to produce heparin sodium, failed to notify FDA of this manufacturing arrangement, and affirmatively represented that ‘no contract firms are involved in the manufacturing of the drug substance, Heparin Sodium USP, that is the subject of th[e] Drug Master File.’”

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