USFDA pulls up Sun Pharma for manufacturing lapses in Halol plant

14 Jan 2023 Evaluate

The US Food and Drug Administration (USFDA) has pulled up drug major Sun Pharmaceutical Industries 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 USFDA pointed out various lapses at the Halol plant which produces finished pharmaceutical products. The health regulator inspected the manufacturing facility from April 26 to May 9, 2022.

Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

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