Torrent Pharma gets 3 observations from USFDA for Gujarat facility

Published On 2022-09-29 07:45 GMT   |   Update On 2022-09-29 07:45 GMT
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Ahmedabad: Drugmaker, Torrent Pharma, has recently announced that the US Food and Drug Administration (USFDA) has issued a "Form 483" with 3 observations at the end of the inspection at the company's manufacturing facility at Indrad, Gujarat.

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.

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The inspection was conducted from 19-September-22 to 28-September-22.

"None of these observations were related to data integrity. We will respond to the USFDA within the stipulated timeline and work closely with USFDA to address the observations at the earliest," the company stated in a BSE filing.

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

Read also: Torrent Pharma appoints Manish Choksi as Independent Director

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