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. Cantronic Systems Inc. - 613542 - 07/20/2023
  1. Warning Letters

CLOSEOUT LETTER

Cantronic Systems Inc. MARCS-CMS 613542 —

Product:
Medical Devices
Recipient:
Recipient Name
James Zahn
Recipient Title
Chief Executive Officer
Cantronic Systems Inc.

#8-62 Fawcett Rd
Coquitlam BC V3K 6V5
Canada

james.zhan@cantronics.com
Issuing Office:
Center for Devices and Radiological Health

United States

Dear James Zahn:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613542, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.

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 in the future.


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:
Dallas Thomas
FDAbasics LLC
15815 SW 11th Court Road
Ocala, FL 34473
dallas@fdabasics.com

Back to Top