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FDA issues warning letter to Mylan after inspections

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Wednesday, Nov. 23, 2011

Federal drug safety inspectors found "significant violations" at a Mylan Inc. manufacturing plant in Puerto Rico during inspections early this year, the Food and Drug Administration said.

The FDA sent what it calls a warning letter to Mylan CEO Robert Coury in October telling him that Mylan's initial response to the violations was insufficient. The letter, the first Mylan ever received, had to do with the plant failing to maintain and test for uniformity in some drugs it produces at the plant in Caguas, Puerto Rico.

"You should take prompt action to correct the violations detailed in this letter," the FDA's warning letter states. "Failure to promptly correct these violations may result in legal action without further notice."

Canonsburg-based Mylan, the world's third largest generic drug maker, is working with the FDA to address the problems at the plant and expects to "resolve this matter expeditiously," spokeswoman Nina Devlin said.

"Production and shipment of product from the Caguas facility continues uninterrupted," she said.

Analysts who follow Mylan said investors should not be too concerned with the letter.

"It only took 50 years, but FDA finally found something apparently worth issuing a warning letter to Mylan," Elliot Wilbur, analyst with New York-based Needham & Co., said in a research note.

Other than Mylan getting its first warning letter in history, Wilbur said it's "a nonevent" because the plant's production in not affected and the plant is not tied to any of Mylan's major product introductions coming in the next two years.

"While Mylan indicated that it takes the warning letter for the Caguas, Puerto Rico facility seriously, it is immaterial in terms of manufacturing capacity," said analyst David Buck, of Buckingham Research Group Inc., New York.

Mylan stock traded at $17.69 this afternoon, down 20 cents on the New York Stock Exchange.

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