Last Updated on December 30, 2023 by The Health Master
The US Food and Drug Administration (USFDA) has issued a warning letter to Sun Pharmaceutical Limited about manufacturing errors at its Gujarat-based plant, including failing to follow the necessary documented procedures intended to avoid microbiological contamination of drug goods.
From April 26 to May 9, 2022, the manufacturing facility was under inspection by the health authority.
The Halol plant, which creates finished pharmaceutical products, was found to have a number of violations, according to a warning letter from the USFDA.
“This warning letter summarizes substantial violations of Current Good Manufacturing Practice (CGMP) standards for finished pharmaceuticals,” the USFDA wrote in the warning letter.
In its other warning letter to the Mumbai-based company, the USFDA cited the drug company’s failure to establish and adhere to appropriate written procedures that are intended to prevent microbiological contamination of drug products that are claimed to be sterile, and that include validation of all aseptic and sterilisation processes.
Warning letter further states:
- Your drug goods are adulterated because your manufacturing, processing, packing, or holding processes, facilities, or controls don’t follow CGMP guidelines.
- Your firm failed to undertake activities within clearly defined zones of suitable size and to have separate or defined areas or such other control measures necessary to prevent contamination r mix-ups in aseptic processing facilities.
- Your ISO 5 cleanroom spaces used for aseptic compounding and filling were inadequately protected and poorly built.
- Sterile drug goods are exposed in the ISO 5 region, making them susceptible to contamination.
- Your firm failed to employ equipment that is of proper design, adequate size, and suitably positioned to facilitate operations for its intended use, as well as for its cleaning and maintenance.
- Significant findings in this letter demonstrate that your company does not operate an effective quality system in accordance with CGMP.
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