USFDA cites manufacturing lapses at Zydus Lifesciences' Gujarat plant

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USFDA cites manufacturing lapses at Zydus Lifesciences' Gujarat plant - Business Standard

Quick Summary:

In a warning letter to company's Managing Director Sharvil Patel, the US Food and Drug Administration (USFDA) noted that the drug maker failed to investigate contamination identified in drug products at its Jarod-based plant in Vadodara district.

"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," it added.

The US health regulator has pulled up Zydus Lifesciences for manufacturing lapses at its Gujarat-based plant.