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  5. Nomax Inc - 512566 - 08/21/2018
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CLOSEOUT LETTER

Nomax Inc MARCS-CMS 512566 —

Product:
Medical Devices

Recipient:
Recipient Name
Charles L. Voellinger
Recipient Title
President and CEO
Nomax Inc

9735 Green Park Industrial Drive

Saint Louis, MO 63123-7241
United States

clvoellinger@nomax.com
Issuing Office:
Center for Devices and Radiological Health

555 Winderley Place #200
Maitland, FL 32751
United States

(407) 475-4700

Dear Mr. Voellinger:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS Case: 512566), dated December 15, 2016. 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/

Blake Bevill, MS
Program Division Director
Division of Medical Devices and Radiological Health
Operations II Central