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  5. Certify Global Inc. - 613568 - 12/13/2024
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CLOSEOUT LETTER

Certify Global Inc. MARCS-CMS 613568 —

Product:
Medical Devices
Recipient:
Recipient Name
Marc Potash
Certify Global Inc.

9801 Washingtonian Boulevard
Suite 200
Gaithersburg, MD 20878
United States

marc.potash@certifyglobal.com
Issuing Office:
Center for Devices and Radiological Health

United States

Secondary Issuing Offices

United States

Dear Marc Potash:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 613568, dated March 4, 2021. 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/
Kellie B. Kelm, Ph.D.
Acting Office Director
OHT 3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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