New Delhi: Drug major Lupin on Monday said the US health regulator has completed the prior approval inspection (PAI) of its Aurangabad manufacturing plant.
During the inspection, the US Food and Drug administration (USFDA) issued one 483 observation, Lupin said in a statement.
“The observation was procedural in nature and corrected during the inspection itself,” it added.
As per USFDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.
The FDA Form 483 notifies the company’s management of objectionable conditions.
Last week, Unit 1 of Lupin’s Pithampur facility had successfully undergone inspection on good manufacturing practice (GMP) as well as PAI by USFDA.