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  5. Regalo's Favorite of Hawaii Inc. - 508259 - 04/05/2019
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CLOSEOUT LETTER

Regalo's Favorite of Hawaii Inc. MARCS-CMS 508259 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
Ruby Ho
Recipient Title
President
Regalo's Favorite of Hawaii Inc.

421 N. King Street
Honolulu, HI 96812
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

1431 Harbor Bay Parkway
Alameda, CA 94502
United States

510-337-6700

Dear Ms. Ruby Ho:

The Food and Drug Administration has completed an evaluation of Regalo’s Favorite of Hawaii, Inc. corrective actions in response to our Warning Letter 508259 dated December 28, 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/
for/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food
Division 5 West