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Indian Supplier for Drugmakers Warned by U.S. FDA

An Indian company that says it supplies ingredients for major drugmakers was warned by U.S. regulators for forging test results and failing to properly clean equipment.

The Food and Drug Administration is stepping up enforcement in India where growing quality concerns have led the agency to ban U.S. sales from some factories. Canton Laboratories Private Ltd. of Vadodara, India, was warned in a letter dated Feb. 27 for a variety of manufacturing practices, including reporting results for tests it never performed to measure microorganisms in active ingredients and failing to ensure equipment was cleaned to prevent contamination.

As a result of the agency’s crackdown, factories run by Ranbaxy Laboratories Ltd. and Wockhardt Ltd., both based in India, have been banned from supplying drugs to the U.S. after being warned for manipulating test results and poor sanitation. FDA Commissioner Margaret Hamburg visited India to discuss quality issues last month. Ranbaxy and Sun Pharmaceutical Industries Ltd., also based in India, are separately recalling cholesterol-lowering and diabetes pills after complaints of bottling mix-ups listed in an FDA enforcement report March 5.

The FDA’s letter posted online today stemmed from a nine-day inspection of Canton in April 2013.

The FDA also issued Mumbai-based USV Ltd. a warning letter dated Feb. 6 that accused the company of manipulating tests.

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