Torrent Pharma gets one USFDA observation for Pithampur facility

Written By : Ruchika Sharma |Medically Reviewed By : Kamal kant gupta Published On 2024-09-19T17:30:39+05:30 | Updated On 19 Sept 2024 5:30 PM IST

Unichem Labs Pithampur facility gets USFDA EIR

Ahmedabad: Torrent Pharma has announced that the United States Food & Drug Administration (USFDA) has issued one observation at the end of a routine GMP inspection at the Company's Formulation manufacturing facility located at Pithampur, Madhya Pradesh.

The inspection was conducted between 16-Sep-24 to 20-Sep-24.

"At the end of the Inspection, the Agency issued a Form FDA 483 with one observation which is procedural in nature. We will respond to the USFDA within the prescribed time-frame and will work in close collaboration with the Agency to address the observation at the earliest possible time," Dr Reddy's Labs stated.

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.

Read also: Torrent Pharma gets USFDA EIR for Indrad 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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Ruchika Sharma

Kamal kant gupta