FDA officials say Ranbaxy knowingly submitted misleading lab information about the safety and efficacy of drugs it produced and planned to distribute in the US.
And given the sordid history between the US regulatory agency and the gigantic India-based generic drug producer, the FDA has decided to forego all work on Ranbaxy drug applications until the company gets its act together.
The transgressions occurred at the company’s Paonta Sahib facility which produces 25 drugs that have already been approved by the FDA.
However the agency refused to provide a list of affected drugs because it has “no concern about the safety or efficacy of Ranbaxy’s drugs on the US market.”
That’s according to Deborah Autor, the FDA’s director of compliance.
In one instance, Ranbaxy employees refrigerated drug samples that were supposed to be tested at room temperature or higher for shelf life.
Other tests to assure drugs maintained potency over time were carried out on the same day or just days apart, according to the Washington Post.
And records show that lab results were validated by employees who weren’t on the premises the day the tests were run.
“These…findings indicate a pattern and practice of submitting untrue statements of material fact and other wrongful conduct,” the FDA hissed in a letter to Ranbaxy.
Ranbaxy had to know this was coming. It had been warned twice in 2006 by the FDA that its inspectors had found numerous deviations from safe, proper manufacturing practices.
Then last September, the FDA banned imports of 28 Ranbaxy-produced drugs after discovering ineffective sterilization procedures, inadequate protections against contamination from allergy-causing ingredients, and incomplete records at Paonta Sahib and elsewhere.