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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Eastern Cranial Affiliates, LLC - Closeout letter


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

Public Health Service
Food and Drug Administration
 Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
Fax: (410) 779-5707

June 8, 2011

Certified Mail
Return Receipt Requested

Mr. Joseph F. Terpenning, C.O.
Eastern Cranial Affiliates, LLC.
1600 Wilson Blvd
Suite 200
Arlington, VA 22209

Dear Mr. Terpenning:

The Food and Drug Administration has completed an evaluation ofyour firm's corrective actions in response to our Warning Letter 128630 dated November 16, 2010. 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 oftaking 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 fmn 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.


Anne Aberdeen
Compliance Officer
Baltimore District