The FDA in 2017 ripped Indian drugmaker Lupin in a warning letter for not learning from past mistakes. In a new visit to one of the two plants cited in that letter, the FDA has again found issues.
Lupin in an announcement said (PDF) the FDA had cited its unit 2 plant in Indore, India, a finished formulations facility, with six observations following an inspection that concluded last week. It provided no details about the nature of the observations, saying only, “The company is confident of addressing the observations satisfactorily.”
In the warning letter just over a year ago, the FDA mostly raised issues about product testing and ordered Lupin to retest batches of drugs that the drugmaker had released for sale in the U.S. even though repeated testing found they failed to meet specifications. Lupin employees had disregarded the out-of-spec results as “outliers.” At Lupin’s plant in Indore, analysts ignored nearly all of the initial out-of-spec testing results—134 of 139 in a two-year period, the FDA said.
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The agency pointed out in the letter that Lupin had tried to resolve most of its repeat issues by simply retraining analysts instead of making changes to its testing methods or equipment so that errors might not occur in the first place.
On top of testing issues, the FDA criticized the Indore plant for “excessive” hold times on APIs that might be contributing to some of the OSS issues and then releasing batches made with those APIs without including them in its stability testing program.
The regulatory issues, along with the difficult generics market in the U.S., have taken a toll on the company’s top line. For the fiscal year that ended in March, Lupin’s sales turned south, posting a 9.1% decline to Rs 155.6 billion (about $2.15 billion), and it took a $227 million impairment on Gavis, a U.S. generic drug company for which it paid $880 million in 2016.
