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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Rebuilder Medical, Inc. - Close Out 4/10/11

  

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

Public Health Service
Food and Drug Administration
 

Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
Fax: (410) 779-5703

FEI: 3004987960

August 10, 2011

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Dr. David B. Phillips, CEO
ReBuilder Medical, Inc.
636 Treeline Drive
Charles Town, WV 25414

Dear Dr. Phillips:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 167912 dated March 8, 2011. Based on our evaluation, it appears that you have adequately 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/

Anne Aberdeen
Compliance Officer
Baltimore District

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