U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Kanetoku Corporation - Close Out Letter 5/24/17
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Kanetoku Corporation May 24, 2017

Kanetoku Corporation - Close Out Letter 5/24/17


Kanetoku Corporation

 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

VIA EMAIL

May 24, 2017

Mr. Shoji Tomiyama, Factory Manager
Kanetoku Corporation
Sasayama Factory
Izumi Complex
Sasayama-shi, 669-2406
Hyogo Pref., Japan

Dear Mr. Tomiyama:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #392714, issued February 13, 2013. 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/

Maria G. Corpuz
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition