Diasol Inc.

CLOSEOUT LETTER Diasol Inc. MARCS-CMS 535734 — March 15, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Monica F. Abeles Recipient Title President Diasol Inc. 310 S 43rd Ave. Ste B Phoenix , AZ 85009 United States mabeles@diasol.com Issuing Office: Los Angeles District Office United States Dear Ms. Abeles: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #535734-17) dated September 25, 2017. 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/ Jessica Mu Director, Compliance Branch Office of Medical Device and Radiological Health Operations Division 3 Content current as of: 03/23/2022 Regulated Product(s) Medical Devices