Hangzhou Facecare Cosmetics Co., Ltd.

CLOSEOUT LETTER Hangzhou Facecare Cosmetics Co., Ltd. MARCS-CMS 537146 — June 28, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name John Wu Recipient Title General Manager Hangzhou Facecare Cosmetics Co., Ltd. No. 755 Yinhai Road HEDA Hangzhou Shi Zhejiang Sheng , 310018 China Issuing Office: Center for Drug Evaluation and Research 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Mr. Wu: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 320-18-09 dated November 17, 2017. 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 FDA 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/ Bryce Hammer Compliance Officer Global Compliance Branch IV Division of Drug Quality II CDER/OC/OMQ Content current as of: 07/17/2019 Regulated Product(s) Drugs