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FDA finds faults at China plant that makes heparin ingredient(Milwaukee Journal Sentinel, The (KRT) Via Thomson Dialog NewsEdge) Apr. 22--A Wisconsin-owned plant in China that manufactures a recalled drug ingredient needs to clean up its plant and processes, the Food and Drug Administration told the company Monday. In a warning letter to Changzhou SPL Co., the FDA said an inspection in late February revealed "significant deviations" from good manufacturing practices in making an active ingredient in the blood thinner heparin. The Changzhou facility is owned and operated by Waunakee-based Scientific Protein Laboratories. According to the FDA's findings: --Changzhou SPL "failed to perform adequate tests to detect impurities" and did not demonstrate that its processes could effectively remove impurities. --The company did not effectively evaluate suppliers of raw materials, and in at least one instance used raw materials from a source that it had deemed "unacceptable" in a preliminary audit. --Equipment used to manufacture the heparin ingredient was "unsuitable for its intended use." Manufacturing tanks did not have properly documented cleaning procedures, and "an unidentified material" was observed adhering to the inside surfaces of tanks. The FDA said two written responses from the company -- one from March 17, the other from April 15 -- were taken into account in the warning. The agency noted that "some corrections appear to have been implemented, and that [Changzhou SPL] promised that others will soon be implemented." Scientific Protein Laboratories supplies heparin's active ingredient to Baxter International, which recalled the drug in January after a number of allergic reactions prompted fears of contamination. Since January 2007, 62 people have died from allergic reactions after taking heparin. The FDA suspects Chinese raw materials for the drug were contaminated with a hard-to-detect derivative of animal cartilage that closely resembles heparin. Chinese officials have disputed this stance, saying that adverse side effects have appeared in uncontaminated batches as well. In a statement, Scientific Protein Laboratories said it did not believe the FDA warning letter "reflects Changzhou SPL's actual state of compliance" with good manufacturing practices. Changzhou SPL already has responded to the FDA's concerns, the company said, adding that it believes certain allegations -- such as the use of a subpar supplier -- already have been "disproven conclusively." The company reiterated a number of earlier statements, saying: --The contaminant in question was introduced into the supply chain before raw materials reached the Changzhou facility and appeared elsewhere in the supply chains of other companies. --Pre-recall testing requirements were unable to detect the contaminant. --None of the FDA's observations have suggested that contamination occurred in Changzhou. The company also emphasized that the warning letter pertained only to the Changzhou site, not its Waunakee facility. On its Web site, Scientific Protein Laboratories says it runs the Changzhou facility with "the same work processes and quality and regulatory compliance discipline which we have practiced so successfully in Waunakee for almost 30 years." The Associated Press and Bloomberg News contributed to this report. To see more of the Milwaukee Journal Sentinel, or to subscribe to the newspaper, go to http://www.jsonline.com. Copyright (c) 2008, Milwaukee Journal Sentinel Distributed by McClatchy-Tribune Information Services. For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA. |