FDA Issues Import Alert on Apotex Products

Generic pharmaceutical company Apotex (Toronto) says the U.S. FDA has issued an import alert that applies to products manufactured at two of Apotex’s facilities in Canada. The alert relates to observations made following routine audits for products meant for the U.S. market, Apotex says. The import alert is following an inspection of the facilities in late 2008 which found deviations from U.S. cGMP (current good manufacturing practices), and a warning letter sent to the company in June 20009, press reports say. “We are actively working with the FDA to...

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