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  5. Allergan Medical - Leter - 03/08/2016
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Allergan Medical - Leter

Allergan Medical - Leter

United States

Issuing Office:

United States


Department of Health and Human Services' logoDepartment of Health and Human Services

 Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

MAR 8 2016

John W. Smith
Regulatory Affairs Director
2525 Dupont Drive
Irvine, California 92612

Dear Mr. Smith:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS #459702) dated May 29, 2015. Based on our evaluation, it appears that your firm has 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 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 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 yours,


Keisha R. Thomas, M.S., M.H.S.
Acting Director
Division of Premarket and
   Labeling Compliance
Office of Compliance
Center for Devices and
   Radiological Health

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