US FDA issues import alert to Apotex’s Indian drug plant

FDA inspected the plant in January and reported that the methods and controls used in its manufacture and control of pharmaceutical products do not appear to conform to current good manufacturing practices (cGMP).
Apotex Pharmachem is a global fully integrated API, R&D and manufacturing organization with its headquarters located in Brantford, Ontario, Canada and is a member of the Apotex group of companies. Apotex produces more than 300 generic pharmaceuticals. The company has multiple facilities around the world located in Canada, India, Mexico, and China. The company said that it was working closely with the FDA to resolve the problems.