USFDA pulls up Intas Pharma for mfg lapses
image for illustrative purpose
The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including violation of current good manufacturing practice (CGMP) regulation, at its Ahmedabad-based plant.
In a warning letter to the company’s CEO and MD Nimish Chudgar, the US Food and Drug Administration (USFDA) has pointed out various manufacturing lapses at the Matoda-Sanand, Ahmedabad-based facility. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
The USFDA inspected the facility from May 1-12, 2023. “This warning letter summarises significant violations of CGMP regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated,” it noted.
