The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant.
The US Food and Drug Administration (USFDA) identified a number of violations at the Halol plant, which creates finished pharmaceutical products, in a warning letter.
"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.
When the US health agency determines that a manufacturer has flagrantly broken its rules, a warning letter is sent.
Failed to adhere to protocols
The USFDA criticised the Mumbai-based company in a letter for failing to create and adhere to documented protocols that involve validating all aseptic and sterilisation processes and are intended to avoid microbiological contamination of drug items that are claimed to be sterile.
"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.
The health regulator also pointed out the firm's failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.
"Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP," it noted.
FDA warned that if problems are not corrected, it may refuse to allow products made by Sun Pharmaceutical Industries Ltd. in Halol into the US.
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