Uckele Health & Nutrition, Inc.

CLOSEOUT LETTER Uckele Health & Nutrition, Inc. MARCS-CMS 540533 — October 09, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Reference #: FY18-HAFE6-04 Product: Dietary Supplements Recipient: Recipient Name Michael J. Uckele Recipient Title CEO Uckele Health & Nutrition, Inc. 5600 Silberhorn Highway Blissfield , MI 49228 United States Issuing Office: Office of Human and Animal Food Division East 6 550 W. Jackson Blvd. Suite 1500 Chicago , IL 60661 United States Dear Mr. Uckele: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (FY18-HAFE6-04, dated March 6, 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/ Byron Ho, DVM Compliance Officer Office of Human and Animal Food Division East 6 Content current as of: 10/10/2019 Regulated Product(s) Dietary Supplements