US FDA issued one 483 observation but corrected during the inspections itself
Lupin has completed of a Prior Approval Inspection (PAI) carried out by the US FDA at its Aurangabad manufacturing facility. The US FDA issued one 483 observation while inspecting the facility.
The company in its BSE filing said, “The observation was procedural in nature and corrected during the inspection itself.”
PAI is performed to contribute to FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.
Last week, the company has sucessfully completed a Good Manufacturing Practice (GMP) inspection as well as a Prior Approval Inspection (PAI) for its Pithampur manufacturing facility – Unit 1 without any observations.