FDA clears Mylan plant after probe

FDA has sounded the all-clear on Mylan. After investigating allegations of quality control problems at its Morgantown, WV, plant, the agency has given the manufacturing facility its blessing. "This officially closes the FDA's investigation and the agency plans no additional action," FDA spokeswoman Judy Leon told Reuters.

As you know, the Pittsburgh Post-Gazette ran a story based on an internal company report, raising questions about the plant's adherence to quality control procedures. Over the next few days, Mylan stock bounced around as news of an FDA probe broke, then CEO Robert Coury said the probe was complete, then the FDA said it was not. (Future textbook example of how not to handle news of an FDA investigation, we think.)

Just after the Post-Gazette's story broke, Mylan said it had investigated deviations from standard procedures and found no impact on product quality. Mylan said the internal report itself was evidence that its quality systems were working--evidence that it fully investigated any problems that arose. Well, the FDA agreed, saying that Mylan's internal investigation was adequate.

Coury got the chance to officially tout the end of the probe, saying in a release that Mylan's Morgantown plant maintains a "gold standard" for quality. He took a couple of shots at the Post-Gazette, too, saying the "biased" article touched off "baseless speculation." Coury wrapped up by saying, "I would like to thank all of our employees for their continued hard work and execution, and I am pleased that this investigation is formally behind us."

- see the Mylan release
- read the Reuters piece
- get more from the Dominion Post

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