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  5. Inova Genomics Laboratory - 577422 - 05/24/2019
  1. Warning Letters

CLOSEOUT LETTER

Inova Genomics Laboratory MARCS-CMS 577422 —

Product:
Medical Devices
Recipient:
Recipient Name
Ramaswamy Iyer
Recipient Title
Director
Inova Genomics Laboratory

3300 Gallows Road
Claude Moore Building, 2nd Floor
Falls Church, VA 22042
United States

Issuing Office:
Center for Devices and Radiological Health

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Dear Dr. Iyer:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 577422, dated April 4, 2019). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA 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.

Sincerely yours,
/S/
Timothy T. Stenzel, M.D., Ph.D.
Director
Office of In Vitro Diagnostics and
Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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