World Organic Corp.

CLOSEOUT LETTER World Organic Corp. MARCS-CMS 441366 — December 17, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Paul J. Licata Recipient Title President World Organic Corp. World Organic Corp. 5242 Bolsa Avenue Suite 3 Huntington Beach , CA 92649-1054 United States Issuing Office: Center for Devices and Radiological Health 19701 Fairchild Irvine , CA 92612-2506 United States Dear Mr. Licata: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #32-16, issued June 17, 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/ Compliance Branch Director Office of Human and Animal Food Division of Human and Animal Feed West 5 Content current as of: 10/10/2018