Torrent hit with Form 483

May 14, 2019

An inspection of a Torrent Pharmaceuticals plant in Indrad, India has resulted in observations from the FDA. 

After investigating the company’s facility from January 2017 to March 2019 and then conducting an inspection in April 2019, the agency found that in hundreds of cases, batches at Torrent’s plant did not meet its testing specifications. The Form 483 document, which was recently made public, also said that the company then failed to review batch discrepancies, even when they had already been distributed.

Torrent is also one of several companies at the center of a widespread recall of losartan potassium tablets, a blood pressure medication, due to contamination with NMBA, a chemical linked to cancer. Torrent has had to recall 114 lots of the medication. Mylan and Teva have also recalled losartan products, and so far, over 2 million bottles of the medication have been pulled from the market.