Inova Genomics Laboratory - 577422 - 05/24/2019
- Medical Devices
Recipient NameRamaswamy Iyer
- Inova Genomics Laboratory
3300 Gallows Road
Claude Moore Building, 2nd Floor
Falls Church, VA 22042
- Issuing Office:
- Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993
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.
Timothy T. Stenzel, M.D., Ph.D.
Office of In Vitro Diagnostics and
Office of Product Evaluation and Quality
Center for Devices and Radiological Health