The FDA on Oct. 15 issued a warning letter to India-based Torrent Pharmaceuticals, targeting the drug company as one of the primary contributors to the onslaught of BP drug recalls in the past year.
Torrent manufactures losartan potassium tablets—one of three angiotensin receptor blockers (ARBs) that have seen frequent recalls since last December. Alongside valsartan and irbesartan, losartan has been under continuous investigation for the presence of probable human carcinogens, including N-methylnitrosobutric acid (NMBA) and N-nitrosodiethylamine (NDEA), in certain batches of pills.
Torrent first issued a voluntary recall of two lots of their losartan potassium tablets last winter after in-house testing revealed traces of NDEA in the drugs. In January the company expanded the recall to 10 lots, then 16, before pulling an additional 104 lots of losartan off the market in April.
In March, Torrent again announced a voluntary recall of 60 lots of losartan potassium tablets and 54 lots of losartan potassium/hydrochlorothiazide tablets due to traces of NMBA.
“Because your methods, facilities or controls for manufacturing, processing, packing or holding do not conform to current good manufacturing practice, your drug products are adulterated,” Francis Godwin, director of the offices of manufacturing quality and compliance at the Center for Drug Evaluation and Research, wrote in his Oct. 8 letter to Samir Mehta, the CEO of Torrent. “Your firm did not appropriately follow your written and approved process validation protocol which required quality attributes to be met for ‘three consecutive’ batches to qualify an alternative active pharmaceutical ingredient.”
Godwin emphasized that if Torrent fails to correct its current violations, it will likely be hearing from the FDA again. Mehta is expected to respond to the letter with a retrospective, third-party review of its products presently on the U.S. market and a comprehensive review and remediation plan for out-of-specification (OOS) result investigation systems, among other points.
“The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility/in connection with your products,” Godwin wrote. “You are responsible for investigating and determining the causes of these violations and for preventing their recurrence or the occurrence of other violations.”