USFDA pulls up Intas Pharma for mfg lapses

New Delhi The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including failure of its quality control unit to ensure CGMP compliance, at its Sanand-based manufacturing plant.

In a warning letter dated July 28, 2023, the US Food and Drug Administration (USFDA) pointed out various manufacturing lapses at the plant. "This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," the USFDA said. It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.."

The USFDA inspected the manufacturing facility from November 22 to December 2, 2022. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.