FDA Slams Torrent Over Losartan Manufacturing Lapses

Megan Brooks

October 16, 2019

The US Food and Drug Administration (FDA) has fired off a warning letter to Torrent Pharmaceuticals, citing several violations regarding its manufacture of losartan potassium tablets at the company's facility in Taluka-Kadi, Gujarat, India.

The letter, addressed to Torrent CEO Samir Mehta, summarizes "significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals."

They include "failure to follow written procedures for production and process control designed to [ensure] that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess."

The letter also cites the company's "failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed."

The company also must "investigate and determine the causes of these violations and devise ways to prevent their recurrence or the occurrence of other violations," the letter states.

Torrent is one of several sartan manufacturers involved in the ongoing global investigation into nitrosamine impurities in angiotensin II receptor blockers (ARBs), such as valsartan, losartan, and irbesartan.

Last month, as reported by Medscape Medical News, Torrent Pharmaceuticals announced an expanded recall of contaminated sartans to include three more lots of losartan potassium and two more lots of losartan-hydrochlorothiazide combination tablets.

The nationwide consumer-level recall was sparked by detection of trace amounts of the potential carcinogen N-Methylnitrosobutyric acid (NMBA) above acceptable daily intake levels set by the FDA.

It was the fifth expanded recall for the company, after it first announced the recall of two lots of losartan potassium tablets December 20, 2018 owing to the presence of another probable carcinogen, N-Nitrosodiethylamine (NDEA), in the API manufactured by Hetero Labs.

The FDA keeps an updated list of recalled ARBs on its website.

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