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  5. YAMAHARU COMPANY - 05/18/2017
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CLOSEOUT LETTER

YAMAHARU COMPANY

Recipient:
YAMAHARU COMPANY

United States

Issuing Office:

United States

 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740
 

May 18, 2017

Mr. Yasuhiro Yamazaki, President
5-2-1 Tsukiji, Chuo-Ku
Tokyo, Japan 104-005

Dear Mr. Yasuhiro Yamazaki:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #438001 September 24, 2014. 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/

Maria Corpuz
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance 

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