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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ivu Imaging Corp - Close Out Letter 9/19/11

  

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

Public Health Service
Food and Drug Administration
 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128
 


September 19, 2011

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mark L. Stribling, CEO
Ivu Imaging Corporation
4121 Grace Lane
Grapevine, Texas 76051

Dear Mr. Stribling:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, 2010-DAL-WL-14, issued on August 31, 2010. 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/

Shari J. Shambaugh
Director, Compliance Branch
Dallas District Office