Regulatory Guidance / Batch

FDA calls out Torrent as key contributor to major recall

Oct 17, 2019

The FDA has issued a warning letter to Torrent Pharmaceuticals and said the company is at the center of its investigation into a global recall of several blood pressure medications. 

According to an update on the recall from the agency, Torrent has received a warning letter for its facility in Gujarat, India — the same site that was hit with a Form 483 in May for failing to review batch discrepancies and for batches not meeting testing specifications.

Torrent is one of the companies that makes losartan, which, along with valsartan and irbesartan, has been subject to a global recall due to nitrosamine impurities.

The FDA said that there were several manufacturing violations at the Torrent facility including “failure to follow written procedures for production and process control and failure to adequately investigate batch discrepancies. The agency says that Torrent would have to correct the violations or face further action.

Torrent recently issued a statement saying that it is committed to quality manufacturing and that it is working with the FDA to resolve the issues.