Tropic Fish Hawaii, LLC

CLOSEOUT LETTER Tropic Fish Hawaii, LLC MARCS-CMS 501652 — March 30, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Tropic Fish Hawaii, LLC United States Issuing Office: United States Office of Human and Animal Foods Division West 5 San Francisco District Office 1431 Harbor Bay Parkway Alameda, CA 94502 Telephone: 510-337-6700 UNITED PARCEL SERVICE SIGNATURE REQUIRED March 30, 2018 Mr. Shawn Tanoue, President Tropic Fish Hawaii, LLC 2312 Kamehameha Hwy, Unit E-5 Honolulu, HI 96819 RE: WL #501652 Close-Out Letter Dear Mr. Tanoue: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter WL#501652 dated July 27, 2016. Based on our evaluation, it appears that you have addressed the violations 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/ Director Compliance Branch Office of Human and Animal Food Division 5 West Content current as of: 04/11/2018