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FDA is increasing international inspections and collaborative enforcement efforts

Heparin contamination

  • 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

© 2009 Hogan & Hartson LLP. All rights reserved.

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