U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Diamond Head Seafood Wholesale, Inc. - Close Out Letter 9/16/14
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Diamond Head Seafood Wholesale, Inc. Sep 16, 2014

Diamond Head Seafood Wholesale, Inc. - Close Out Letter 9/16/14

Diamond Head Seafood Wholesale, Inc.
  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700

 

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED


September 16, 2014


Gary T. Ishimoto, President
Diamond Head Seafood Wholesale, Inc.
966 Robello Lane
Honolulu, Hawaii 96817


Dear Mr. Ishimoto:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated August 8, 2012. 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/

Lawton W. Lum
Director, Compliance Branch
San Francisco District

 

cc: Michael Irish, CEO