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  5. Shin Ho Sing Ocean Enterprise Co., Ltd. - 506326 - 10/05/2018
  1. Warning Letters

CLOSEOUT LETTER

Shin Ho Sing Ocean Enterprise Co., Ltd. MARCS-CMS 506326 —


Recipient:
Recipient Name
Martin K. L. Lin
Recipient Title
Assistant General Manager
Shin Ho Sing Ocean Enterprise Co., Ltd.
Shin Ho Sing Ocean Enterprise Co., Ltd.

No. 31 Fishing Harbor
South 1st Road
Kaohsiung City 806
Taiwan

Issuing Office:
Public Health Service

United States


Dear Mr. Lin:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #506326, issued September 30, 2016. Based on our evaluation, it appears you have addressed the violations contained in the 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/
Brandon Bridgman
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

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