Tuesday, July 28, 2009

FDA Cracks Down on Apotex in Canada

Apotex has experienced a high number of rejected batches and FDA is cracking down on this generic brand company in Toronto. XStream endorses a comprehensive materials analysis process within the supply chain to protect end users to appropriate quality and control.

Canada's Apotex Inc could face a freeze on new drug applications in the United States as well as a ban on products entering the country after the U.S. Food and Drug Administration warned it of a number of
manufacturing breaches at a Toronto factory.

The June 25 warning, which followed a late 2008 inspection of the Etobicoke, Ontario facility, cited a number of manufacturing deviations from U.S. manufacturing codes.

Among the breaches, the agency charged that Apotex did not thoroughly investigate the failure of batches of some drugs and also noted an unusual high number of rejected batches.

To view article visit: www.reuters.com

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