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."