Shanghai Neo-Medical Import & Export Co., Ltd.

CLOSEOUT LETTER Shanghai Neo-Medical Import & Export Co., Ltd. MARCS-CMS 477444 — June 16, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Pei Zhang Recipient Title General Manager Shanghai Neo-Medical Import & Export Co., Ltd. Room 2004, B/D3 183 Huai Hai Xi Rd. Shanghai Shi , 200000 China Issuing Office: Division of Infection Control and Plastic Surgery Devices United States Dear Mr. Zhang: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 477444, dated November 10, 2015). 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/ Cynthia J. Chang, Ph.D. Director Division of Infection Control and Plastic Surgery Devices Office of Health Technology 4: Surgical and Infection Control Devices Center for Devices and Radiological Health CC: Marco Mu Mid-link International Inc 2219 Rimlang Drive, Suite 301 Bellingham, WA US 98226 Content current as of: 06/23/2020 Regulated Product(s) Medical Devices