Nomax Inc

CLOSEOUT LETTER Nomax Inc MARCS-CMS 512566 — August 21, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 09/13/2018 Regulated Product(s) Medical Devices