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

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

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

The USFDA in the warning stated – “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.”

In the other warning letter to the Mumbai-based company, the USFDA pointed out failure of the drug firm 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 sterilisation 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.

“Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance,” USFDA said.

“Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP,” it added.