“Drug Products Adulterated”: US Regulator Warns Sun Pharma’s Gujarat Plant
Drug giant Sun Pharma has been criticised by the US health authorities for manufacturing errors at its Gujarat-based plant, including failing to follow the proper documented procedures intended to avoid microbiological contamination of drug goods. 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.
From April 26 to May 9, 2022, the manufacturing facility was under inspection by the health authority.
When the US health agency determines that a manufacturer has flagrantly broken its rules, a warning letter is sent. 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.
The company was also criticised by the health agency for failing to fully investigate any apparent disparity or batch or component failure to meet any requirements.
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