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Pharmaceuticals / Inspections and Audits

Indian Generics Producer Missed Mark on Tests, FDA Says

Nov. 20, 2017

A major manufacturer of generic drugs in India failed to follow up as required on laboratory tests that showed its products at two facilities did not meet specifications, in some cases improperly dismissing the red-flag results, the FDA said in a warning letter.

Lupin was cited on the basis of inspections at its Goa branch in March-April and at its Indore plant in May.

At the Goa plant, technicians conducted an assay for an active ingredient in a production batch of medicines and came up with out-of-specification results. Repeated retests yielded similar results, until only a final test produced a different outcome, the FDA said.

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