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Warning letter shows vulnerabilities of crude heparin used in API

By Mari Serebrov
Regulatory Editor

Tuesday, November 29, 2016

Despite EU and U.S. concerns about Dongying Tiandong Pharmaceutical Co. Ltd.’s sourcing and testing of crude heparin, the FDA waited more than a year after inspecting the company’s API plant in Shandong, China, to send it a warning letter.

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