Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com

CLOSEOUT LETTER Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com MARCS-CMS 613952 — September 27, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Mr. Edward Mauro Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com Nature’s Distributing; Club Clean Inc 107 Pinckney St Oldsmar , FL 34677 United States Kody@ClubClean.net Ed@ClubClean.net Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Mauro: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613952, May 28, 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 yours, /S/ Donna Engleman, MS, BSN Director Division of Market Intelligence Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 10/04/2021 Regulated Product(s) Medical Devices