Great Lakes Gelatin Company

CLOSEOUT LETTER Great Lakes Gelatin Company MARCS-CMS 612323 — November 05, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FY21-HAFE6-03 Product: Dietary Supplements Recipient: Recipient Name James Burkett Recipient Title President Great Lakes Gelatin Company 253 Commerce Dr. Ste. 101 Grayslake , IL 60030 United States JamesB@greatlakesgelatin.com Issuing Office: Office of Human and Animal Food Operations East-VI United States Dear Mr. Burkett, The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY21-HAFE6-03. Based on our evaluation, it appears that you have addressed the violation(s) 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/ Kelli Wilkinson LCDR Director of Compliance HAFE6 division Content current as of: 11/05/2021 Regulated Product(s) Dietary Supplements