US FDA Finds Poor Data Integrity At Second Intas Plant

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. 

The facility is just eight kilometers up National Highway 47 from Intas’ Matoda plant, where in November FDA investigators found that workers had undercounted microbiological colonies in environmental monitoring...

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