USFDA flags concerns over Lupin’s plant

MUMBAI: Lupin said on Monday that the US Food and Drug Administration (FDA) has raised concerns over manufacturing processes at the company’s Pithampur plant.
The USFDA inspected the plant in January this year, after which it issued the company ‘Form 483’ listing six observations on the manufacturing processes, Lupin said in a BSE statement, without giving details.In a Form 483, the FDA typically outlines conditions or practices at a unit that may cause the products made there to be in violation of the US agency’s standard production requirements.