Ami Cosmetics Co., Ltd.

CLOSEOUT LETTER Ami Cosmetics Co., Ltd. July 11, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Ami Cosmetics Co., Ltd. United States Issuing Office: United States Center for Drug Evaluation and Research Silver Spring, MD 20993-0002 July 11, 2018 Kyung Rok Lee AMI Cosmetic Co. 19 Yanghwa-Ro Mapu-Gu, Seoul KOR (Republic of Korea) 121-888 Kyung Rok Lee: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 1040, issued June 12, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. 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: 07/11/2018 Regulated Product(s) Drugs