FDA on Apotex's case for plant problems

Canada's Apotex, already in NAFTA fight with U.S. over a 2009 FDA import ban, has found itself back in the FDA doghouse.  

The generic drug manufacturer, which for nearly two years had its products banned from the U.S., has received a warning letter for two of its plants in Canada, one in Ontario and another in Toronto that has received a warning letter before. 

Among other problems, inspectors found issues with air flow that could lead to contamination. The company was criticized for releasing partial batches of products after some had failed testing. And when lack of space and "personnel resource constraints" kept it from dealing with some filled vials, they sat for about a week before going into incubation.

The warning letter noted several of the problems had been cited in earlier inspections, evoking this from the agency: "The evidence suggests that Apotex has failed to implement adequate global and sustainable corrective and preventive actions and that it continues to manufacture and distribute pharmaceutical product without upholding its legal obligation to comply with CGMP. FDA's inspections continue to find repeated deficiencies in your quality systems." It went on to imply that the company figure out how to fix the issues and make sure they stay fixed. 

In a statement, the company says it prides itself on making "top-quality generic pharmaceuticals" and is working diligently with the FDA to get the problems fixed. 

But it was a statement similar to those issued after warning letters in 2009 and 2010 for the Toronto plant and for a different facility in Ontario. Those letters discussed contaminated drug ingredients, the return of defective material to inventory and the re-release of failed material prior to sufficient reprocessing and testing. Those problems led Apotex to recall 675 lots of products. After that, Apotex was barred from selling drugs in the U.S. from August 2009 until May 2011. 

Once the ban was lifted., Apotex complained to NAFTA that the FDA action "decimated" its business and cost it $520 million in lost sales. It argued that the ban violated the North American Free Trade Agreement, claiming the FDA treated Apotex less fairly than other companies, like Teva Pharmaceutical ($TEVA). Apotex is asking the treaty oversight agency for arbitration in an effort to get the U.S. to reimburse it. 

Steve Giuli, Apotex's director of government affairs and industry relations, said Wednesday: "The complaint is a pending matter, and, as such, we have no comment to offer on it." 

- read the warning letter
- here's the Apotex release