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 of 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.
Lupin improperly declared that the initial, failing result was an “outlier,” despite the repetition of the finding in retests and the inability to determine why that result was obtained. The company also inappropriately applied its outlier judgment in other cases, the agency said.
In addition, the facility held ingredients for final products “for excessive periods” without adequately examining the effect on the ingredients, the FDA said.
At the Indore facility, Lupin also missed the mark on investigation of hold times, the agency said.
The company committed test miscues in Indore similar to those flagged in Goa. In the period 2015-16, the company invalidated 134 out of 139 initial OOS results and blamed them on laboratory error, without always establishing that was the cause, the letter said.
The company’s response to the inspectors’ findings was not adequate, the agency said.