New Delhi: 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. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products.
“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, news agency PTI reported
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. In the letter to the Mumbai-based company, the USFDA pointed out that the drug firm had failed 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.
What it further said
Failure to address violations may also result in the FDA refusing admission of articles manufactured at Sun Pharmaceutical Industries Ltd, Halol, into the US, the regulator said.
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