FDA Issues Warning Letter To Torrent Pharmaceuticals

FDA Issues Warning Letter To Torrent Pharmaceuticals

Introduction

On October 8, the FDA issued a warning letter to Torrent Pharmaceuticals over its manufacturing plant in India involving the active pharmaceutical ingredient (API) in losartan.

The letter is a result of an inspection earlier this year, according to which there were around 340 batches of finished products tested as out of specification (OOS) over two years, and the manufacturer retested 73% of them, reversing the initial findings without any explanations. The retested products were then shipped to the U.S. and abroad.

The warning letter issued to Torrent’s Taluka-Kadi, Indrad, Gujarat facility outlines the following manufacturing violations:

• Failure to follow written procedures for production and process control and failure to adequately investigate batch discrepancies. 

• Failure to correct these violations may result in further action by the agency.

Several lots of generic valsartan and losartan hypertension medications, manufactured by Torrent Pharmaceuticals, have been recalled since August 2018, after finding that the drugs contained elevated levels of N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) or N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Exposure to these recalled drugs is linked to reports of liver cancer, stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer, and other digestive tract cancers.