Torrent Pharmaceuticals was hit with a Form 483 by the FDA that cited the Indian drugmaker with three observations outlining possible contamination and improper investigations into lab failures.
The U.S. regulatory agency outlined three main observations in a 15-page response to Torrent following a September inspection of the company’s Taluka-Kadi production facility in Indrad, Gujurat, India. The plant, which has a troubled past and drew FDA ire several years ago, manufactures tablets, capsules and vials, according to the company’s website.
During its most recent inspection, FDA inspectors found residue from previous manufacturing operations had not been cleaned, leading them to conclude the company's cleaning process was substandard. The agency cited one tank that was marked as “cleaned” but was “encrusted with a fine white to off-white color power residue and flakes in product contact areas.” Inspectors also observed damage and other indications of wear and tear on the equipment.
The FDA also found a litany of failures involving laboratory investigations that triggered a “cascade” of issues. Specifically, the company “frequently invalidated out-of-specification and laboratory incident investigations without an adequate investigation leading to potential root causes of manufacturing equipment and laboratory glassware cleaning issues," the FDA said.
Torrent was also cited for not including the findings of a drug complaint in its written records.
In 2019, the FDA called out Torrent as one of the main culprits in a global recall of high blood pressure medicines tainted with a suspected carcinogen. The maelstrom that swirled around Torrent concerning nitrosamine impurities in angiotensin II receptor blockers such as valsartan, losartan and irbesartan, involved violations at the Taluka-Kadi plant.