USFDA pulls up Sun Pharma for lapses in Halol plant

16 Jan 2023 , 03:00 PM

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

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

‘This warning letter summarizes 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 commented.

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

A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. In the letter to the company, the USFDA pointed out drug firm’s failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.

‘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,’ it said.

It further said, ‘Your ISO 5 cleanroom areas used for aseptic compounding and filling were poorly designed and lacked adequate protection.’

The ISO 5 area is critical because sterile drug products are exposed and therefore vulnerable to contamination, it added.

At around 3:00 PM, Sun Pharma was trading at Rs1035.05 per share higher by 0.44% on the BSE.

For feedback and suggestions, write to us at [e-mail]