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FDA scolds Mylan for ‘repeated’ manufacturing problems

Before legal troubles and a challenging generics market wiped out much of its value, Mylan was an industry titan with a glowing manufacturing record to match.

“There was a time, of course, that the very thought of Mylan receiving an FDA warning letter was unthinkable, as the company had the longest unblemished [Good Manufacturing Practice] track record in the industry,” Elliot Wilbur, an analyst at Raymond James, wrote in a note to clients this week.

The record has been blemished in recent years, though. In 2018, the FDA warned Mylan about its manufacturing plant in Morgantown, West Virginia.

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