Shenzhen Weifa Technology Co., Ltd

CLOSEOUT LETTER Shenzhen Weifa Technology Co., Ltd MARCS-CMS 609828 — September 27, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Huaquan Yu Shenzhen Weifa Technology Co., Ltd Room 403, Building 117, Sungang Village, Baogang Road Sungang Street Shenzhen Shi Guangdong Sheng , 518100 China info@starkit.com Issuing Office: Center for Devices and Radiological Health United States Dear Huaquan Yu: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 609828, March 11, 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: 09/27/2021 Regulated Product(s) Medical Devices