U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Mylan Pharmaceuticals Inc. - 557903 - 05/11/2020
  1. Warning Letters

CLOSEOUT LETTER

Mylan Pharmaceuticals Inc. MARCS-CMS 557903 —

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

Back to Top