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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 2008 inspection of the Etobicoke, Ont., facility, cited several deviations from U.S. manufacturing codes.

The agency noted an unusual number of rejected batches and charged Apotex didn't thoroughly investigate the failure of 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."

The FDA also said the company failed to meet the required time-frame for alerting the agency about significant chemical or physical changes in distributed drugs.

"Until all corrections have been completed and FDA has confirmed corrections of the deficiencies and your firm's compliance ... this office may recommend withholding approval of any new applications or supplements listing your firm as a drug product manufacturer," the letter said. "In addition, failure to correct these violations may result in FDA denying entry of articles manufactured at Apotex Inc. Etobicoke, Canada into the U.S."

Last month, U.S. authorities seized all products produced by generic drug maker Caraco Pharmaceutical Laboratories Ltd. following repeated violations of manufacturing standards.

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