FDA is increasing international inspections and collaborative enforcement efforts
Following Jan. 2008 CDC reports on increases in allergic reactions and low blood pressure associated with heparin, including 81 deaths, FDA identified a previously unknown contaminant in heparin, oversulfated chondroitin sulfate
FDA notified key international partners, through Rapid Alert Notification System, and initiated an Import Alert
FDA discovered that the contamination affected at least ten other countries, implicating at least ten Chinese firms in supply chain
FDA discovered serious cGMP deficiencies, misrepresentations, and unreported sub-manufacturing by Chinese API manufacturers
Nov. 2008 – FDA established three offices in China, all reporting to Mac Lumpkin
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