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. Suisan Company, Ltd - Close Out Letter 8/17/17
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Suisan Company, Ltd


Suisan Company, Ltd

 

  

Black HHS-Blue FDA Logo

 

San Francisco District Office
1431 Harbor Bay Parkway, Alameda, CA 94502
Telephone: 510-337-6700 

 
 

UNITED PARCEL SERVICE
SIGNATURE REQUIRED

August 17, 2017

Glenn Hashimoto or Stephen N. Ueda, President/CEO
Suisan Company, Ltd.
333 Kilauea Avenue, Suite 202
Hilo, Hawaii 96720

RE: CMS # 497820

Dear Mr. Hashimoto or Mr. Ueda:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS # 497820), dated June 14, 2016. Based on our evaluation, it appears that you have addressed the violation(s) 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/

Darla Bracy, District Director
 

cc: Kasey N. Ah Yo, Fish Division Manager
Suisan Company, Ltd.
93 Lihiwai Street
Hilo, Hawaii 96720