The FDA has cited Torrent Pharmaceuticals' troubled Indrad manufacturing facility in Gujarat, India, with an Official Action Indicated (OAI) letter as part of an inspection last September that resulted in a Form 483.
In a Jan. 24 filing (PDF) with the Bombay Stock Exchange, the company said the U.S. regulatory agency determined the inspection classification as an OAI. Torrent added that “this inspection classification will not have an impact on existing supplies or revenues from this facility.”
The company said it will continue to cooperate with the FDA.
The agency cited the Indian drugmaker with three observations in a scathing 15-page report following the September inspection of the Taluka-Kadi production facility.
FDA inspectors found residue from previous manufacturing operations had not been cleaned, leading them to conclude the company's cleaning process was substandard. Inspectors also observed damage and other indications of wear and tear on the equipment and a number of failures involving laboratory investigations that triggered a “cascade” of issues.
The agency said the Torrent facility “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.” In 2019, the FDA cited Torrent as one of the central figures in a global recall of high blood pressure medicines tainted with a suspected carcinogen that involved violations at the Taluka-Kadi plant.