USA – FDA 483s Pile Up in Crackdown on Sartan Manufacturers in India

In line with efforts to assess the impact and sources of the sartan safety scandal, India-based Torrent Pharmaceuticals and Cadila Healthcare separately drew lengthy US Food and Drug Administration (FDA) Form 483s over, among other issues, failures to thoroughly review unexplained discrepancies.

The manufacturing site inspection at Torrent Pharmaceuticals FDA investigators conducted over the course of about a week last month resulted in four inspectional citations, with the 483 largely focusing on that firm’s investigations into out-of-specification (OOS) results. FDA’s visit to Cadila Healthcare’s site from late April to early May revealed 14 observations of manufacturing deficiencies.

Torrent Pharmaceuticals and Cadila Healthcare are manufacturers of sartan products that have been recalled, including valsartan, olmesartan, irbesartan and losartan. Both 483s were made public earlier this month, underscoring FDA transparency around efforts to work with manufacturers to remove angiotensin II receptor blocker (ARB) drug products with impurity levels above interim acceptable limits.

Deficiencies in Cadila Healthcare’s unexplained discrepancy review procedures relate to complaints and a lack of assignable root casues. Those observed at Torrent Pharmaceuticals relate to OOS results investigations…