Apotex Inc., a closely held Canadian drugmaker, manipulated quality testing data at its plant in India, bringing into question the ingredients it uses to make medicines, U.S. regulators said.
The Food and Drug Administration posted a warning letter it sent Apotex yesterday that says an inspection found workers at the generic-drugmaker’s Bangalore, India, plant retested active ingredients until they got desirable results and dismissed signs of contamination. The FDA asked for a list of Apotex ingredients in circulation and said it may withhold approval of new product applications if the medicines are planned to be made with raw materials from the plant.
Apotex’s India plant was banned April 1 from sending drugs and antibiotics to the U.S. The FDA has prohibited imports from other Indian companies that make generic drugs, including Ranbaxy Laboratories Ltd (RBXY) and Wockhardt Ltd (WPL), for similar test manipulation. FDA Commissioner Margaret Hamburg visited India in February to discuss quality issues with drugmakers and plans to increase staff and inspections there.
“The above examples raise serious concerns regarding the integrity, reliability and accuracy of the data generated and available at your facility,” the FDA wrote Apotex President and Chief Operating Officer Jeremy Desai.
The FDA inspection of the plant took place Jan. 27-31. Apotex had previously been cautioned in 2006 and 2010 about failing to investigate data that reveals products potentially don’t meet standards, the FDA said.
When the FDA banned drugs and antibiotics from the plant in April, Steve Giuli, director of government affairs and industry relations at Apotex, said the factory only produced pharmaceutical ingredients and that the company was working with the FDA to clarify the plant doesn’t manufacture finished products. Giuli didn’t respond to a phone call or e-mail today seeking comment on the letter and clarifying the import ban.
In response to a detailed observation report the FDA sends companies after an inspection, the agency said Toronto-based Apotex reviewed data from August and September 2013 and found additional incidents in which extra testing was performed.
“You fail to explain why, given these troubling findings, you did not then expand your investigation to discover the full scope of such variances from established procedures,” the FDA said. “Based on findings from these two months, it would be reasonable to believe that improper variances occurred in prior months as well.”
While Apotex acknowledged the deficiencies after the inspection, the company said there was no effect on product quality or patient safety, according to the letter. The FDA questioned the claim given the unreliable and incomplete testing data.
The FDA asked Apotex to “provide a comprehensive evaluation of the extent of the omission, deletion and destruction of records, a risk assessment regarding the potential impact on the quality of products, and a comprehensive corrective and preventive action plan.”
The FDA sent Apotex a warning letter in February 2013 for its Toronto and Ontario facilities that failed to follow procedures to prevent contamination and didn’t properly investigate quality failures. The FDA also issued import alerts for Apotex plants in Canada in 2009 that have since been lifted.
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