FDA hits Torrent Pharma with a Form 483, citing 5 observations

After an FDA inspection of a Torrent Pharmaceutical manufacturing facility in Gujarat, India, the agency has handed the company a Form 483 filing citing several production shortfalls.

The regulatory agency cited five “procedural” observations that inspectors turned up during a pre-approval inspection of the oral dosage manufacturing plant between Dec. 5 and Dec. 11, the company said in a filing with the BSE.

“There was no observation related to data integrity reported,” the company said in the filing. “We will respond to the (U.S.) FDA within the prescribed time frame and will work in close collaboration with the agency to address the observations at the earliest possible time.”

Torrent didn't release any other specifics behind the FDA's report.

Torrent, which was reported in September to be courting Apollo Global Management for a loan of up to $1 billion to help fund its planned bid for Cipla, is no stranger to FDA warnings.

In January, the company was issued an Official Action Indicated (OAI) letter for its Indrad production facility following a scathing 15-page report that resulted from a September 2022 visit. Inspectors found that workers 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 situation involved violations at the firm's Taluka-Kadi plant, the agency said.