The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including its failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant.

In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products.

“This warning letter summarises significant violations of Current Good Manufacturing Practice (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,” the USFDA stated.

The health regulator inspected the manufacturing facility from April 26 to May 9, 2022.

“Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas,” the latter said.

“Your ISO 5 cleanroom areas used for aseptic compounding and filling were poorly designed and lacked adequate protection,” the letter added.