Ranbaxy Generic Drugs Denied Import to U.S. by FDA

Filed in archive Consumer Alert , News on September 16, 2008

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The largest maker of generic drugs in India - Ranbaxy Laboratories Ltd - has been issued a warning letter and an import alert by the FDA in lieu of 30 generic drugs made in its two plants in India.

The two plants whose quality control issues in Ranbaxy's Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The FDA said they will closely monitor and evaluate the situation. The list of 30 generic drugs affected can be found here.

Read more from the FDA News and the US News and World Report.