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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Eiber Radiology, Inc. - Close Out Letter 11/10/11


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

Public Health Service
Food and Drug Administration

555 Winderley Place, Ste. 200
Maitland, Florida 32751
Telephone: (407) 475-4700
FAX: (407) 475-4769

November 10, 2011

Alberto Eiber, M.D.
Eiber Radiology, Inc.
49 West 49th Street
Hialeah, FL 33012

Dear Dr. Eiber:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter FLA-12-03 issued on October 20, 2011. 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 Mammography Quality Standards Act of 1992 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.



Emma R. Singleton
Director, Florida District