USFDA issues warning letter to Glenmark Pharma for lapses at Goa plant
The US health regulator has pulled up drug maker Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish required laboratory control mechanisms, at its Goa-based manufacturing plant.
In a warning letter addressed to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha, the US Food and Drug Administration (USFDA) pointed out various lapses at the company's Bardez-based facility in Goa, which produces drug formulations.
The US Health regulator noted that the "warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals".
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 May 12, 2022, to May 20, 2022.
In the warning letter, the US health regulator pointed out the company's failure "to ...