US FDA raids, shuts Ranbaxy’s US HQ

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The US Food & Drug Administration (FDA) on February 14 shut the US headquarters of India’s largest pharmaceutical company, Ranbaxy Laboratories, in New Jersey, following a full-scale search by “criminal investigators”, according to a report in a local daily, The Trentonian.

A Ranbaxy spokesperson said: “We are not aware of any wrongdoing. The action has come as a surprise, but the company is fully cooperating with officials.” The company’s operations continue as normal, the spokesperson added. The facility remained shut on Thursday and agents from the FDA did not respond to queries from the newspaper that first reported the closure.

“There has to be a justifiable reason for the regulator to send criminal investigators,” an industry observer said.

This is not the first time Ranbaxy has run into trouble with the US FDA. Earlier, in June 2006, the administration had raised questions related to its dosage forms plant at Paonta Sahib, after a site inspection. The company is still waiting “re-approval” from the FDA after a team visited the facility in January this year. The FDA’s action could impact the company’s business in the US, which accounts for 28% of Ranbaxy’s global revenue.