CLOSEOUT LETTER
Amgen, Inc.
- Recipient:
- Amgen, Inc.
United States
- Issuing Office:
United States
| |
| Food and Drug Administration Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human ServicesVIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
January 9, 2015
Mr. Robert A. Bradway
President and Chief Executive Officer
Amgen, Inc.
One Amgen Center Drive
Thousand Oaks, California 91320
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #11-14 issued on January 27, 2014. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District