NATCO Pharma undergoes API facility inspection by US FDA

The regulatory audit resulted in zero observations and no Form 483 was issued

Drug firm Natco Pharma said its Active Pharmaceutical Ingredient (API) facility in Mekaguda near Hyderabad has undergone successful inspection by the US health regulator with zero observations.

The inspection of the companys API facility in Mekaguda has been successfully completed by the United States Food and Drug Administration (US FDA).

The inspection was conducted during February 12-16, 2018, it added.

The regulatory audit resulted in zero observations and no Form 483 was issued, Natco Pharma said.

Form 483 is issued by the USFDA if it finds objectionable conditions at a facility.