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US FDA Finds Poor Data Integrity At Second Intas Plant

 
• By Bowman Cox

After machines counted particles in vials, workers revised reports so out-of-specification batches could be exported to the US and the EU.

Counting particles in vials
the art of counting particles at intas • Source: Shutterstock

A 12 May 2023 inspection of an Intas Pharmaceuticals Ltd. plant in Sarkhej, a suburb of Ahmedabad, India, has uncovered another stunning display of data manipulation at the firm, according to the US Food and Drug Administration’s 15-observation, 29-page Form 483 report of inspectional observations.

according to the US Food and Drug Administration’s Form 483 report of inspectional observations.

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