U.L. Manufacturing Company Ltd.

CLOSEOUT LETTER U.L. Manufacturing Company Ltd. MARCS-CMS 539712 — April 24, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Nadine Kelly-Reid U.L. Manufacturing Company Ltd. 418 Cedar Place Ebony Vale Spanish Town P.O. St. Catherine Jamaica Issuing Office: Center for Food Safety and Applied Nutrition United States Dear Ms. Kelly-Reid: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #539712, issued November 16, 2017. Based on our evaluation, it appears you have addressed the violations contained in the 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/ Maria Corpuz, Supervisor Food Adulteration Assessment Branch Division of Enforcement Center for Food Safety and Applied Nutrition Content current as of: 05/07/2019 Regulated Product(s) Food & Beverages