HMD Biomedical Inc.

CLOSEOUT LETTER HMD Biomedical Inc. MARCS-CMS 499698 — September 02, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Tien-Tsai Hsu Recipient Title President HMD Biomedical Inc. No. 181 Minsheng St. Xinpu Township , Hsinchu County 30548 Taiwan Issuing Office: "OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality" United States Dear Tien-Tsai Hsu: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #499698, dated August 31, 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 yours, /S/ Courtney H. Lias, Ph.D. Deputy Director OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: Tina Jair GL Diabetes Corp 9676 Oviedo St. San Diego, CA 92129 Content current as of: 10/05/2020