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,...
To view the full article, register now.

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.