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CLOSEOUT LETTER

St. Shine Optical Co., Ltd


St. Shine Optical Co., Ltd

 

  

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U.S. Food & Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993

Via United Stated Postal Service


6/21/17

Johnson Chou
Managing Director
St. Shine Optical Co., Ltd.
4,5F No. 276-2 Sec. 1
Ta Tung Road
Hsi Chih Dist., New Taipei City 221
Taiwan
 

Dear Mr. Chou:
 

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 409147) dated August 26, 2013. 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.
 

Sincerely,
/s/
Ronald L. Swann, MS.
Acting Director
Division of International Compliance Operations
Office of Compliance