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Ranbaxy Files Corrective Action Plan with FDA

May 29, 2009 | Parker Waichman LLP

Generic drug maker Ranbaxy Laboratories LTD has filed a corrective action plan with the U.S. Food & Drug Administration (FDA). The FDA barred some of Ranbaxy's drugs from import to the U.S because of violations found during inspections of two plants in India. One of those plants was later cited for falsifying data on new and approved drug applications.

The FDA said it received Ranbaxy's corrective action plan on May 18.  Neither the FDA nor Ranbaxy have disclosed what the plan entails.  “The FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the U.S. market are safe and effective,” FDA spokesman Christopher Kelly said in an e-mail to yesterday. “The next steps will be dependent on the actions identified” in the plan, he said.

Based in India, Ranbaxy is one of the 10 largest generic-drug producers in the world and has been operating in the States since 1995. It has been involved in several scandals over the past year. US prosecutors filed a motion in federal court in Maryland last July alleging that Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the this country.  The investigation was  also looking into allegations that Ranbaxy  made weak or adulterated HIV drugs that were given to thousands of AIDS patients in Africa. Prosecutor also accused the company of concealing violations of good manufacturing practice regulations from FDA.

As we reported last September, the FDA had imposed an import ban on 30 different Ranbaxy drugs  because of the agency’s concerns about the “seriousness and extent” of violations of manufacturing standards at its  Paonta Sahib plant and a second  Ranbaxy facility in India.  At the time, officials said they were concerned about whether the practices employed at the facilities could ensure purity of drugs they made.

In February the FDA also said  the plant in Paonta Sahib faked data and test results in approved and pending drug applications.  Most of the falsified data involved required tests to prove drugs are stable over a certain time period, the agency said.  The problems were discovered during a 2006 inspection, and included drug samples meant for required stability testing stored in refrigerators even though the samples should have been stored at room temperature. Logbooks  also didn’t identify which samples were in the refrigerator or how long they had been there.  The FDA halted the review of drug applications made at Ranbaxy’s Paonta Sahib plant in India because of the issue.

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