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  5. Wickimed Medical Equipment Manufacturing Co., Ltd. - 623042 - 05/23/2022
  1. Warning Letters

CLOSEOUT LETTER

Wickimed Medical Equipment Manufacturing Co., Ltd. MARCS-CMS 623042 —

Product:
Medical Devices
Recipient:
Recipient Name
Mr. Mac Lai
Recipient Title
CEO
Wickimed Medical Equipment Manufacturing Co., Ltd.

XingWang Street, LiLin Town
ZhongKai Hi-Tech Zone
Huizhou Shi
Guangdong Sheng, 516003
China

mac_lai@wickimed.com
Issuing Office:
Center for Devices and Radiological Health

United States

Dear Mr. Lai:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 623042, dated January 7, 2022. 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 nor 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/
Cynthia Long, MD, FACS
Acting Division Director
Division of General Surgery Devices
Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health


CC:
David Lennarz
Registrar Corp144
Research Drive
Hampton, VA 2366

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