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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inova Health Care Services, Inova Blood Donor Services - Close Out Letter 11/29/2012

  

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) 779-5455
Fax: (410) 779-5705

FEI: 1177788

November 29, 2012

Certified Mail
Return Receipt Requested

Mr. Mark S. Stauder, President and COO
Inova Health System, Governance Affairs
8110 Gatehouse Road, Suite 200 East Tower
Falls Church, VA 22042


Dear Mr. Stauder:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 298919 dated May 3, 2012. Based on our evaluation, it appears that you have adequately 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/

Cherlita Honeycutt
Compliance Officer
Baltimore District


Cc: Ms. Terri L. Craddock, Director
      Inova Health Care Services/Inova Blood Donor Services
      45745 Nokes Boulevard, Suite 160
      Sterling, VA 20166

      Mr. Mark S. Stauder, President and COO
      Inova Health System