Intas’ Response To Second Data Integrity Inspection Still Did Not Go Far Enough, US FDA Says

Intas – the the troubled Indian firm at the center of the cisplatin shortage – may have punished workers for their visual-inspection subterfuge, but it also should have gone after managers, the FDA asserted in a second data integrity warning letter in four months.

Ampoule inspection machine
machines counted particles; humans adjusted the counts • Source: Shutterstock

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