FDA Blasts Another Indian Drug Firm Over Suspect Records

Law360, New York (February 25, 2014, 1:27 PM EST) -- The U.S. Food and Drug Administration has found evidence of manipulated data on manufacturing quality at yet another Indian pharmaceutical plant, according to a sharply worded warning letter released Tuesday.

In its letter to USV Ltd., the FDA criticized an array of practices at a testing laboratory, including the use of sample measurements — as opposed to measurements actually recorded during an analysis — to calculate impurities.

Those unreliable calculations, in turn, were submitted to the FDA in support of at least one drug approval application,...
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