FDA probes possible violations at Mylan plant

The media brouhaha over potential manufacturing problems at a Mylan plant has brought out the FDA. The agency says it's a"routine" fact-finding mission, following up on news that employees at a West Virginia manufacturing facility may have violated government-mandated quality control procedures. "FDA is currently conducting fact-finding and investigating the situation," spokesman Christopher Kelly told the Pittsburgh Post-Gazette.

The FDA probe comes after the Post-Gazette obtained an internal report on problems at the plant. According to that report, employees repeatedly overrode alerts of potential problems on the production line. Though there's no proof that the overrides caused actual quality problems with the prescription drugs made at the plant--indeed, Mylan says it found no such quality issues--the report deemed the process violations "pervasive" and "very serious."

Mylan stock dropped more than 10 percent yesterday as the news broke. Meanwhile, the company is facing a WHO probe at its Matrix Laboratories subsidiary in India. WHO inspectors found "major deviations" from good manufacturing practice. The company corrected some of the problems, WHO said, but other issues remain.

- see the Post-Gazette follow-up
- check out the story from Reuters 
- get more from the Pittsburgh Business Times

Suggested Articles

Horizon Therapeutics has notched an FDA approval for its rare eye disease med Tepezza (teprotumumab), a possible blockbuster drug in the making.

Eli Lilly has a pipeline stuffed with a host of assets and has decided it needs a new injectable drug and device plant to manufacture some of them.

After Clovis’ Rubraca snagged an FDA boost in prostate cancer last week, AZ and Merck’s rival Lynparza has matched it with a boost of its own.