Regulatory Focus™ > News Articles > 2019 > 5 > FDA 483s Pile Up in Crackdown on Sartan Manufacturers in India

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

Posted 17 May 2019 | By Ana Mulero 

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.

Other 483 citations at Cadila Healthcare relate to equipment cleaning procedures, procedures to prevent microbiological contamination of drug products purporting to be sterile, aseptic processing areas, the product area, a backup file of data, production and process controls, the quality control unit, laboratory controls and in-process specifications, as well as master production and control records. Torrent Pharmaceuticals’ remaining citations relate to production and process controls, calibration of automatic and electronic equipment and OOS investigations for active pharmaceutical ingredient products.

The latest batch of 483s adds to a growing list of 483s issued to India-based ARB manufacturers amid the sartan safety scandal, which stems from the 2018-detected presence of probable human carcinogens.

Torrent Pharmaceuticals 483
Cadila Healthcare 483

Categories: Regulatory News

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