July 28, 2009 / 2:14 PM / 10 years ago

UPDATE 1-Mylan says FDA finds plant issues were minor

* Mylan said FDA visited plant on Monday

* Shares rise more than 8 percent

NEW YORK, July 28 (Reuters) - Mylan Inc (MYL.O) said on Tuesday that the U.S. Food and Drug Administration had found only a minor deviation in standard procedures at a key manufacturing plant in West Virginia, sending the generic drugmaker’s shares up more than 8 percent.

The agency’s findings come after investors were spooked by an article over the weekend in the Pittsburgh Post-Gazette, which, citing an internal report, said workers overrode quality controls intended to ensure the safety and efficacy of the company’s prescription drugs.

Mylan, the world’s No. 3 generic drugmaker, said it had contacted the FDA over the weekend to notify the agency about the article, and the FDA visited the Morgantown facility on Monday.

The FDA “has determined that the baseless accusations in the article were unfounded,” Mylan said in a statement.

All data were reviewed, and the agency agreed a minor deviation in standard operating procedure existed and that the company fully implemented corrective actions, Mylan said.

“I hope that these actions only reaffirm Mylan’s long-standing reputation as one of the industry’s highest quality manufacturers with a management team that has an unyielding commitment to adhere to the highest quality standards,” Mylan Chief Executive Robert Coury said in a statement.

Mylan shares were up $1, or 8.3 percent, at $13.10 in morning Nasdaq trading, recovering most of Monday’s losses. (Reporting by Lewis Krauskopf; Editing by Lisa Von Ahn)

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