Tuesday, July 14, 2009

Apotex warned as U.S. drug agency cracks down

I have not heard if Health Canada is looking into these issues on our side of the border or not...

From Reuters:
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.

This, the FDA suggested in the letter, "demonstrates a lack of adequate process controls and raises significant concerns regarding the capability and reliability of (Apotex's) processes to consistently manufacture drug products meeting predetermined specifications." ...more

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