USFDA Inspects Aurobindo Pharma's API Unit, Issues 'Form 483' With Four Observations
On 19 May, Aurobindo Pharma's Unit XIV, an API Non-antibiotic Manufacturing facility situated at Paravada Industrial Area, Anakapalli District got inspected by the United States Food and Drug Administration (USFDA) from 15th May to 19th May 2023, the company stated in an exchange filing on Friday.
The USFDA has issued the Form 483 certification to the pharma major with four observations. As per the FDA, a Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The company in a statement said, "The observations are procedural in nature. We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observations at the earliest."
Aurbindo Pharmaceutical's stock was trading 1.81 per cent higher at Rs 600.10 per scrip on BSE as of 13:25 IST.
