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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tetracore, Inc - Close Out Letter 8/23/10

 

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

August 23, 2010

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

William Nelson, Ph.D.
President
Tetracore, Inc.
9901 Belward Campus Drive
Suite 300
Rockville, Maryland 20850

Dear Dr. Nelson:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 86204, dated December 1, 2009. Based on our evaluation, it appears that you have addressed the violation(s) 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/

Nancy L. Rose
Baltimore District Office
Compliance Officer

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