U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Unimicro Medical Systems Shenzhen Co., Ltd. - 624560 - 05/18/2023
  1. Warning Letters

CLOSEOUT LETTER

Unimicro Medical Systems Shenzhen Co., Ltd. MARCS-CMS 624560 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Roly Lee
Recipient Title
General Manager and Co-Founder
Unimicro Medical Systems Shenzhen Co., Ltd.

201, Bldg 38 101 Heshui Kou
Gongmingzhen Longgang
Shenzhen
518106
China

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Roly Lee:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #624560 dated 01/06/2022. 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 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/
Courtney H. Lias, Ph.D.
Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC:
Zeyu Chen
238 Fernwood Ave, Edison, New Jersey 08837

Back to Top