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U.S. FDA Says Chinese Supplier Of Heparin API Never Inspected

This article was originally published in PharmAsia News

Executive Summary

The U.S. FDA blames human error and other problems for never inspecting the facilities of a Chinese supplier of active ingredients contained in Baxter International's heparin product. The product has been linked to four deaths and hundreds of allergic reactions. An FDA spokeswoman said the agency inspected the Baxter facility in New Jersey where the finished version of the drug was made, but because of a series of errors, the Chinese plant was never inspected. She said the agency is preparing to inspect the Chinese facility, which was not identified, as soon as possible. (Click here for more - a subscription may be required

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