- The Food and Drug Administration this week warned Indian drugmaker Torrent Pharmaceuticals about violations at a manufacturing plant run by the company in Gujarat, India that produces the blood pressure medicine losartan.
- During an April inspection, the FDA found the Gujarat site failed to follow proper procedures for quality control and released batches of losartan to the U.S. even after testing failures.
- In addition, multiple investigations into batches of medicine found to be out of specification were closed without Torrent determining the root cause, the FDA wrote in a warning letter dated Oct. 8
Torrent is the latest manufacturer to get a formal warning from the FDA as the agency scrambles to address impurities in blood pressure medicines that have resulted in a flood of recalls. Torrent itself last month expanded a recall of batches of losartan after the tablets tested positive for the carcinogen N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA.
The FDA blames certain manufacturing conditions for creating NMBA and other nitrosamine contaminants. The agency has been investigating companies that produce medicines in the angiotensin II receptor blocker (ARB) class, and last year sent a warning letter to a Chinese manufacturer, Zhejiang Huahai Pharmaceutical, that's been at the center of the scandal.
In Torrent's case, problems have been found before at the company's Indrad facility, the FDA said.
"Repeated failures at multiple sites demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," the regulator wrote.
Among other demands, The FDA asked Torrent for a review of all data that supports its quality control procedures for commercially available products, a third-party review of failed tests that were invalidated and a summary of the report from a consultant engaged by the company.
The FDA is also investigating the presence of a carcinogen found in the generic heartburn medicine ranitidine, commonly known by its brand name Zantac. In that case, unacceptable levels of a potentially cancer-causing contaminant called N-nitrosodimethylamine, or NMDA, have been identified in tested batches.