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Heartway Medical Products Co., Ltd

Heartway Medical Products Co., Ltd

United States

Issuing Office:

United States


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
 Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993


Via United Parcel Service

JUL 16 2015

Mr. Yung Ho
Managing Director, President and Chairman
Heartway Medical Products Co., Ltd
No. 6, Road 25, Taichung Industrial Park
Taichung, 408
Taiwan, R.O.C.

Re: FEI # 3002847480

Dear Mr. Yung Ho:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated March 7, 2012 (CMS# 270236). 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 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 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.



Carl Fischer, Ph.D.
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health

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