Torrent Pharma gets 5 USFDA observations for Indrad facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-06-13 06:39 GMT | Update On 2024-06-13 06:39 GMT
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Ahmedabad: Through a recent BSE filing, Torrent Pharma has informed that the US Food and Drug Administration (USFDA) has issued Form 483 with five observations at the end of the inspection at the Company’s manufacturing facility situated in Indrad, Gujarat.
A Pre-Approval Inspection (PAI) and a GMP inspection were conducted from 03-Jun-24 to 12-Jun-24.
"There was no observation related to data integrity reported. We will respond to the USFDA within the prescribed time-frame and will work in close collaboration with the agency to address the observations at the earliest possible time," the firm stated.
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