Volume 88 Issue 24 | pp. 28-31
Issue Date: June 14, 2010

FDA Struggles To Keep Up In India

Facility inspections are declining in the country that supplies the most generic drugs to the U.S.
Department: Business, Government & Policy
Keywords: Foreign Inspection, FDA, India

When Strativa Pharmaceuticals announced in February that it could not launch a new product, the only reason, the New Jersey-based firm said in a statement, was that the U.S. Food & Drug Administration had not inspected the plant in India where the drug was to be made because of “an agency-wide restriction on foreign travel to India.”

A record obtained by C&EN of FDA’s inspections of Indian pharmaceutical facilities during . . .

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