Inspections, Compliance, Enforcement, and Criminal Investigations
Inova Health Care Services, Inova Blood Donor Services - Close Out Letter 11/29/2012
| 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 |
Department of Health and Human ServicesFEI: 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
