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  5. Seiki Co., Ltd. - Close Out Letter 3/28/18
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CLOSEOUT LETTER

Seiki Co., Ltd. Mar 28, 2018

Seiki Co., Ltd. - Close Out Letter 3/28/18


Recipient:
Seiki Co., Ltd.


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

March 28, 2018

Mr. Kenji Kuroiwa
President
Seiki Co., Ltd.
7922-3 Kiire Maenohama-Cho
Kagoshima City, Kagoshima Prefecture
Japan 891-0205

Dear Mr. Kuroiwa:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #523744, issued June 1, 2017. 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
Team Leader
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
     and Applied Nutrition