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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An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Torrent Pharma is an Indian multinational pharmaceutical company headquartered in Ahmedabad, India. The company specializes in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC).

Read also: Torrent Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC

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