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Canada's largest drug manufacturer is facing a ban on some of its exports to the United States after an inspection of its factory revealed what the United States Food and Drug Administration considers "significant deviation" from its manufacturing guidelines.

The FDA has issued an Import Alert for Toronto-based Apotex Inc., which produced 300 generic drugs that fill 85 million prescriptions each year worldwide.

It only affects products destined for the U.S.

"We are actively working with the FDA to resolve the identified concerns as quickly as possible, and are optimistic that there will be a prompt resolution," Apotex said in a statement.

In a June 25 warning letter, the FDA said inspections of the company's Etobicoke facility showed several deviations from U.S. manufacturing codes. The agency alleged Apotex didn't thoroughly investigate the failure of batches.

This, the FDA suggested, "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," according to the letter.

Apotex says the alert only affects two of its "many facilities," which are spread across 11 Canadian cities. The company employs 5,800 people in Canada.

The action comes as the FDA continues to crack down on manufacturing breaches among generic drug companies. The FDA recently seized the products made by Michigan-based Caraco Pharmaceutical Laboratories Ltd. for repeated manufacturing violations.

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