FDA takes next step in Torrent Pharmaceuticals' troubled India plant saga, issues OAI

26 Jan 2023
endpts.com
The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India. Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given. “This inspection classification will not have impact on existing supplies or revenues from this facility. Torrent Pharma continues to cooperate with the USFDA and will undertake all necessary remedial steps to resolve these issues to the satisfaction of the regulator. Torrent Pharma remains committed to being cGMP compliant quality standards across all its facilities,” Torrent’s letter said. The new letter stems from an FDA inspection in September that recorded three observations at Torrent’s manufacturing site in the village of Indrad, in the state of Gujarat in the nation’s east. According to the company, the site manufactures tablets, capsules and vials. The FDA’s 15-page 483 filing revealed that manufacturing equipment in several areas had residue from previous materials that should have been removed. The inspectors also noted methods to monitor cleaning were not up to par, a tank that had been marked “cleaned” was “encrusted with a fine white to off-white color power residue and flakes in product contact areas,” and dents and changes to the shape of equipment were also noted. Endpoints News reached out to Torrent for comment on the OAI but did not receive a response by press time. The Torrent facility is not the only manufacturing site in the country to come under the FDA’s microscope. The FDA handed down an OAI to a Sun Pharma manufacturing facility in Halol, India, in 2020, according to a report from the Indian news site Business Standard , with the Halol facility recently given an import alert from US regulators as well.
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