Mylan is committed to maintaining the highest quality manufacturing standards at its facilities around the world. In support of this commitment, Mylan’s plants are regularly inspected by health authorities to ensure compliance for the various markets we serve. The U.S. Food and Drug Administration (FDA) recently completed an inspection at Mylan’s plant in Morgantown and made observations through a Form 483. The company has submitted a comprehensive response to the Agency and committed to a robust improvement plan.
We remain confident in the quality, safety and efficacy of our drug products, including those in distribution, and we continue to manufacture and ship product from the site. Mylan will continue to maintain a close dialogue with the Agency and is fully committed to working with FDA to address its observations.