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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Wendell Corporation dba Regalo Bakery - Close Out Letter 9/18/13


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


September 18, 2013

Ms. Ruby B. Ho, President
Regalo's Favorite of Hawaii, Incorporated
421 North King Street
Honolulu, Hawaii 96817

Dear Ms. Ho:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated August 29, 2012, and our reference case number CMS 347700. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Our investigators verified corrections during our April 16-24, 2013 inspection, and the remaining corrections were verified in your response to our Regulatory Meetings conducted over the phone on August 21, August 27, and September 3, 2013. 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.




Lawton W. Lum
Director, Compliance Branch
San Francisco District