Torrent Pharma has announced that the United States Food and Drug Administration (USFDA) has conducted 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. PAI is performed to provide the USFDA assurances that a manufacturing site named in a drug application is capable of consistently manufacturing a safe drug product, and that the submitted data is accurate and complete against what was filed in their application.
"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.
