Jessie Commodity Co., Ltd.

CLOSEOUT LETTER Jessie Commodity Co., Ltd. MARCS-CMS 576935 — May 20, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: #1271 Product: Drugs Recipient: Recipient Name David Wei Jessie Commodity Co., Ltd. Yuyao Jessie Commodity Co. Ltd. No. 67 Zhenxing West Road Yuyao Zhejiang Sheng , 315400 China Issuing Office: Center for Drug Evaluation and Research United States Dear Mr. David Wei: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1271, issued on April 18, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and delisted the product. Future FDA 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 to continue to monitor your state of compliance. Your firm is expected to maintain the current contact information with FDA. Labeler code contact information, including physical address, email and other contact information, must be updated within 30 calendar days after any change to that information. 21 CFR § 207.33(c)(2). FDA uses this information for official communication regarding registration and listing matters. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection, submission review 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: 05/29/2019 Regulated Product(s) Drugs