United Exchange Corporation

CLOSEOUT LETTER United Exchange Corporation MARCS-CMS 565551 — November 30, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Ellen Chang United Exchange Corporation United Exchange Corporation 17211 Valley View Ave. Cerritos , CA 90703 United States Issuing Office: Center for Drug Evaluation and Research United States Dear Ellen Chang: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1285, issued on October 29, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and delisted the product by the way of including a marketing end date. Future FDA regulatory activities will further assess the adequacy and sustainability of these actions. 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 to 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 Rossana R. Cook Director Office of Program and Regulatory Operations Office of Compliance Center for Drug Evaluation and Research Content current as of: 12/04/2018