Shanghai Neo-Medical Import & Export Co., Ltd. MARCS-CMS 477444 —
- Medical Devices
Recipient NamePei Zhang
Recipient TitleGeneral Manager
- Shanghai Neo-Medical Import & Export Co., Ltd.
Room 2004, B/D3
183 Huai Hai Xi Rd.
Shanghai Shi, 200000
- Issuing Office:
- Division of Infection Control and Plastic Surgery Devices
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.
Cynthia J. Chang, Ph.D.
Division of Infection Control and Plastic Surgery
Office of Health Technology 4: Surgical and
Infection Control Devices
Center for Devices and Radiological Health
Mid-link International Inc
2219 Rimlang Drive, Suite 301
Bellingham, WA US 98226