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  5. Jessie Commodity Co., Ltd. - 576935 - 05/20/2019
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CLOSEOUT LETTER

Jessie Commodity Co., Ltd. MARCS-CMS 576935 —

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