FDA warns Mylan on 'significant violations' of cGMP regs at Indian facility

12 April 2017

The US Food and Drug Administration (FDA) has warned Netherlands incorporated Mylan (Nasdaq: MYL) that unless it addresses manufacturing violations at its facility in Maharashtra, India, then the agency could withhold approval of any new applications or supplements listing the firm as a drug manufacturer.

The letter was released by the FDA on Tuesday, when Mylan’s share price dropped by 2% to $38.45, and it marks the latest manufacturing setback for the company following news of its recall of EpiPen (epinephrine) Auto-Injector devices distributed in the USA and around the world.

"Until you correct all violations completely and we confirm your compliance with CGMP, the FDA may withhold approval of any new applications"

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