US FDA finds no deficiencies at Mylan plant

The US Food and Drug Administration has released its official and final report regarding the agency's review of allegations made in a July newspaper article concerning drugmaker Mylan's  Morgantown, West Virginia, manufacturing facility, finding no deficiencies at the facility. The FDA inspected the plant after a Pittsburg Post-Gazette report raised questions about the plant late last month, and on July 28 the company issued a statement saying the agency found only a minor deviation.

The newspaper article, which included unfounded and highly inaccurate allegations, was based on improperly obtained documents, uninformed third-party commentary and anonymous sources, said Mylan, the world's number three generics company. The final FDA report closes the inspection with no deficiencies found and no FDA "483" issued. The company shares, which tumbled after the Post-Gazette published its report, rose 3 % to $14.01 in morning trading.

Mylan chief executive Robert Coury said: "The baseless speculation that was caused by a highly irresponsible and sensational newspaper article with a biased agenda was entirely unnecessary. Our customers and stakeholders recognize that there is no one in a better position to speak about issues such as these than a company's senior management or the applicable regulatory agency. It would be a mistake for anyone to rely on uninformed sources.'