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High Spot Health Technology Co. Ltd. MARCS-CMS 471170 —

High Spot Health Technology Co. Ltd.

United States

Issuing Office:

United States



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10903 New Hampshire Avenue
Silver Spring, MD 20993 

December 7, 2017

Hsin Yuan Chen
Chief Executive Officer
High Spot Health Technology Co. Ltd.
102 Dung Sei 7th Road, Da-An District
Taichung City, Taiwan 43954

Dear Mr. Chen:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS Case #471170] dated August 25, 2015. Based on our evaluation, it appears that you have addressed the violations 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.


Valerie A. Flournoy
Acting Director
Division of Manufacturing and Quality
Office of Compliance
Center for Devices and Radiological Health

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