The United States Food and Drug Administration (US FDA) on January 2 released detailed report on five procedural observations it made at Torrent Pharma's Chhatral unit in Gujarat earlier last month.
The site manufactures oral solid dosages for oncology, according to a report. This was a pre-approval inspection conducted from December 5 to 11. The observations mentioned that the company had failed to review any unexplained discrepancy and it did not have procedures applicable to the quality unit in writing.
The Form 483, citing the observations, noted that components for manufacturing were not weighed and measured properly in the plant and that the accuracy and specificity of test methods have not been established.
The report also added that equipment in the plant were not cleaned and maintained at appropriate intervals.
Shares of the company traded 0.65 percent up at Rs 2311.15 intraday on January 2.
Also read: Brokerages forecast strong growth for Torrent Pharma after robust Q2 show
"We will respond to the USFDA within the prescribed timeframe and will work in close collaboration with the agency to address the observations at the earliest possible time," the company had said in an exchange filing on December 12, soon after the inspection.
In January 2023, Torrent 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”.
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