Torrent Pharma’s Gujarat facility gets 1 observation from USFDA

20 Mar 2023 , 02:43 AM

Torrent Pharmaceuticals announced that its Oral-Oncology manufacturing facility located in Bileshwarpura, Gujarat, has undergone a Pre-Approval Inspection (PAI) by the US Food and Drug Administration (FDA) and has been completed. 

After inspecting the facility, the USFDA has issued a Form 483 containing only one observation.

From March 13 to March 17, the US Food and Drug Administration (USFDA) carried out a pre-approval inspection of Torrent Pharma’s plant situated in Bileshwarpura.

In its bourse filing, Torrent Pharmaceuticals reported “the USFDA conducted a Pre-Approval Inspection (PAI) at its Oral-Oncology manufacturing facility situated in Bileshwarpura, Gujarat from March 13 to March 17. 

The company further stated, ‘at the end of the inspection, we were issued a ‘Form 483′ with one procedural observation.’

According to the filing, the company has stated that it will respond to the USFDA within the prescribed timeframe and will work in close collaboration with the agency to address the observation at the earliest possible time.

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