FDA bans imports from drug facility in Mumbai

Sept. 16, 2013 at 3:27 PM   |   Comments

MUMBAI, Sept. 16 (UPI) -- U.S. product safety regulators said they would ban drug imports from a Ranbaxy Laboratories Ltd. facility in Mumbai that failed a plant inspection.

The U.S. Food and Drug Administration said it found "significant" violations at the company's newest plant in northern India that makes generic drugs.

Among its findings, the FDA cited the company for a "failure to adequately investigate manufacturing problems." The plant was inspected in September and December 2012, The Wall Street Journal reported Monday.

"We have so far not received any communication from the U.S. FDA," a company spokesman said in an email.

The spokesman said the company was "seeking information," from U.S. officials.

The announcement markets the third Ranbaxy plant to cross the line with the FDA and it has the potential to be a long-range problem. The FDA has yet to lift the bans on the other two facilities, which were put into effect in 2008.

In another incident, the company closed a plant in Gloversville, N.Y., that had received a warning letter from the FDA in 2009. Then, last November, the company recalled 480,000 bottles of genetic Lipitor after a routine inspection found evidence of glass fragments.

The company's current Lipitor production will not be affected by the new FDA order, as it is now made by the company in New Jersey, the Journal said.

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