Recipient NameMs. Heather Bresch
Recipient TitleChief Executive Officer
- Mylan Pharmaceuticals Inc.
1000 Mylan Boulevard
Canonsburg, PA 15317
- Issuing Office:
- Office of Pharmaceutical Quality Operations Division I
- (973) 331-4900
Dear Ms. Bresch:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #557903], dated November 9, 2018, and subsequent Regulatory Meeting held on April 17, 2019. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Program Division Director/District Director
Office of Pharmaceutical Quality Operations
Division I/New Jersey District Office