Nikki's Ginger Tea LLC

CLOSEOUT LETTER Nikki's Ginger Tea LLC MARCS-CMS 446205 — March 14, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Nikki's Ginger Tea LLC United States Issuing Office: United States Chicago District Office 550 W. Jackson Blvd., Suite 1500 Chicago, IL 60661 Telephone: (312) 353-5863 Fax: (312) 596-4187 March 14, 2018 VIA UPS Andrena N. Sasser, Co-Owner Monique D. Sasser, Co-Owner Nikki’s Ginger Tea, LLC 231 E. Grand Boulevard Detroit, MI 48207 Dear Mses. Sasser, The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 2015-DET-07, dated March 18, 2015. 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/ Byron J. Ho, DVM Compliance Officer Human and Animal Food Operations Division East 6 Content current as of: 04/16/2018