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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