Original Living Coconut, LLC

CLOSEOUT LETTER Original Living Coconut, LLC MARCS-CMS 561493 — June 15, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Food & Beverages Ice Cream/Frozen Dairy Recipient: Recipient Name Ms. Renee E. Ainlay Original Living Coconut, LLC 817 W. Arnold Wallen Way Stockton , MO 65785 United States Issuing Office: Office of Human and Animal Food-West Div. 2 United States 913-495-5100 Dear Ms. Ainlay: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 561493) on October 10, 2018. 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/ Andrew A. Hoopes Compliance Officer Office of Human and Animal Food-West Div. 2 Content current as of: 06/29/2020 Regulated Product(s) Food & Beverages Ice Cream/Frozen Dairy