TORONTO, July 14 (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.”
The FDA also said the company failed to meet the required timeframe 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 agency said in a letter.
“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.”
The letter comes as the FDA cracks down on manufacturing breaches.
Last month, U.S. authorities seized all products produced by generic drugmaker Caraco Pharmaceutical Laboratories Ltd CPD.A following repeated violations of manufacturing standards.
The company was warned about manufacturing problems in an FDA letter sent in October 2008. ($1=$1.14 Canadian) (Reporting by Scott Anderson, editing by Gerald E. McCormick)