Mylan Pharmaceuticals Inc.

CLOSEOUT LETTER Mylan Pharmaceuticals Inc. MARCS-CMS 557903 — May 11, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Ms. Heather Bresch Recipient Title Chief Executive Officer Mylan Pharmaceuticals Inc. 1000 Mylan Boulevard Canonsburg , PA 15317 United States Issuing Office: Office of Pharmaceutical Quality Operations Division I United States (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. Sincerely, /S/ Diana Amador-Toro Program Division Director/District Director Office of Pharmaceutical Quality Operations Division I/New Jersey District Office Content current as of: 05/12/2020 Regulated Product(s) Drugs