Inspections, Compliance, Enforcement, and Criminal Investigations
Ivu Imaging Corp - Close Out Letter 9/19/11
| Public Health Service Food and Drug Administration |
Dallas District |
Department of Health and Human Services
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
