USFDA Slams Torrent Pharma With Form 483 Citing Five Violations
Torrent Pharma's Indrad plant faces compliance scrutiny with a Form 483 from USFDA, citing five observations post-inspection.
Torrent Pharmaceuticals revealed that the US Food and Drug
Administration (USFDA) issued a Form 483 with five observations following an
inspection of its Indrad, Gujarat, manufacturing plant from June 3 to June
12. The inspection covered both a pre-approval inspection (PAI) and a Good
Manufacturing Practice (GMP) inspection. The company emphasized that no data
integrity issues were identified. Torrent Pharma intends to respond to the
USFDA within the specified timeframe and will collaborate closely with the
agency to promptly mark the observations.
“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," Torrent Pharma stated.
According to the USFDA, a Form 483 is presented to a
company's management at the end of an inspection if the investigator identifies
any conditions that could potentially violate the Food, Drug, and Cosmetic
(FD&C) Act and related legislation.
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