Sooil Development Co., Ltd.

CLOSEOUT LETTER Sooil Development Co., Ltd. MARCS-CMS 607127 — February 21, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Jin-Seok Noh Recipient Title General Manager of Quality Assurance Sooil Development Co., Ltd. Yongin-si Gyeonggi-do 16922 South Korea yoonheey@sooil.com Issuing Office: Center for Devices and Radiological Health United States Dear Jin-Seok Noh: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 607127, dated April 16, 2020). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Feedback related to the November 28 through December 1, 2022, was provided to you via email on February 9, 2023, 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/ Marianela Perez-Torres, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: Jong Hyun Kim SOOIL LLC Jeremy@sooilusa.com Content current as of: 02/24/2023 Regulated Product(s) Medical Devices