Heartway Medical Products Co., Ltd - Close Out Letter 7/16/15
- Heartway Medical Products Co., Ltd
Department 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
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