Torrent Pharma gets 5 USFDA observations for Gujarat facility

Ahmedabad: Torrent Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded the inspection with 5 procedural observations at the Company's Oral-Oncology manufacturing facility situated in Bileshwarpura, Gujarat.

Pre-Approval Inspection (PAI) was conducted from 05 December, 2023 to 11 December, 2023.

"At the end of the inspection, the Company was issued a Form 483 with 5 procedural observations. There was no observation related to integrity reported," the Company stated in a recent BSE filing.

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. 

"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," Torrent further added.

Medical Dialogues team had earlier reported that the USFDA had issued an Establishment Inspection Report (EIR) for the Oral-Oncology manufacturing facility at Bileshwarpura, Gujarat.

Read also: USFDA issues EIR for Torrent Pharma Bileshwarpura facility

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).

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