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LATEST NEWS UPDATES | For Poor Manufacturing Practices, Indian Pharma Company Gets ‘Warning Letter’ From US FDA

For Poor Manufacturing Practices, Indian Pharma Company Gets ‘Warning Letter’ From US FDA

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published Published on Nov 8, 2022   modified Modified on Nov 9, 2022

-TheWire.in

The US drug regulator says Lupin Limited's response to tackling genotoxic impurities was not adequate.

New Delhi: The US Food and Drug Administration (FDA) has sent a warning letter to the Indian pharmaceutical company Lupin Limited after deeming its efforts to address violations of various good manufacturing practices at its facility in Tarapur, Maharashtra “inadequate”.

The FDA sends a ‘warning letter’ to a manufacturer if it has “significantly violated” the agency’s regulations. Violations may be poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The manufacturer is directed to correct the problem within a specific timeframe.

Please click here to read more. 


TheWire.in, 8 November, 2022, https://thewire.in/health/us-fda-warning-letter-lupin-limited-manufacturing


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