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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Herman A. Jenkins, M.D - Close Out Letter 3/21/11

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

MAR 21, 2011

Dr. Herman A. Jenkins
Professor & Chair
Department of Otolaryngology
School of Medicine
University of Colorado
12631 E. 17th Avenue
Mail Stop 8205
Aurora, CO 80045

Dear Dr. Jenkins:

The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter of August 16, 2010. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities may further assess the adequacy and sustainability of these corrections.

This letter does not relieve you 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 FDA expects you 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,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health