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The US FDA has published a list of 22 Chinese companies who fail to comply with the GMP regulations. All companies manufacture Heparin. The FDA states in an import alert: "As part of FDA's activities intended to protect the health and safety of U.S. consumers, FDA often conducts inspections of foreign establishments that produce FDA-regulated articles intended for use in the United States. One basis for detention without physical examination is that the firm's quality system is inadequate for the prevention of contamination or otherwise does not conform to CGMP. Heparin contaminated with oversulfated chondroitin sulfate (OSCS) clearly indicates that the "methods used in" or the "controls used for" the "manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity" with CGMP. OSCS is not part of the manufacturing process for heparin and its presence suggests that somewhere in the supply chain OSCS has been added intentionally to heparin for financial reasons because it is a very cheap material prepared by a simple synthetic process. In addition, it mimics certain heparin properties so that it would pass then current United States Pharmacopeia (USP) specifications for Heparin Sodium USP. (The USP has since revised in 2009 its monograph for Heparin Sodium USP to incorporate tests that can detect the presence of OSCS). Manufacturers must have adequate traceability, qualification, and testing systems in place in order to satisfy applicable CGMP requirements. Where there is an inspection that identifies an inadequate system in this regard, the firm's drug(s) or other products appear to be adulterated and are subject to imports refusal per 801(a)(3). Furthermore, if the firm appears to have been responsible for introducing contaminated forms of heparin or heparin-related products into the supply chain, then there is an appearance that the firm's quality system is inadequate or otherwise does not conform to CGMP. If the firm demonstrates that they have appropriate controls in place, the firm's drugs or other products may no longer appear to be adulterated. The attachment to this alert identifies firms for which we have information indicating that the different forms of heparin or heparin-related products appear to be adulterated for one of the reasons described above. It appears per 801(a) that the methods used in and controls used for the manufacture, processing, packing, or holding of the drugs or other products from the firms listed in the attachment do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B); therefore such articles are subject to refusal of admission into the United States" Details on the companies can be found in the Import Alert published by FDA. Source: FDA Import Alert |
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