WARNING LETTER

Jessie Commodity Co., Ltd. MARCS-CMS 576935 — April 18, 2019

Recipient:: Recipient Name

Wei Jianjian; Jessie Commodity Co., Ltd.; NO.469-3, Fengshan Road
Yuyao
Zhejiang
315400
China

Issuing Office:: Center for Drug Evaluation and Research; 10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

WARNING LETTER

VIA UNITED PARCEL SERVICE

SIGNATURE REQUIRED

April 18, 2019

WL # 1271

Wei Jianjian

Yuyao Jessie Commodity Co., Ltd.

NO.469-3, Fengshan Road

Yuyao, Zhejiang, 315400

China

Dear Wei Jianjian,

The United States Food and Drug Administration (FDA) has reviewed your firm’s listing information provided for Mouth Fresh, NDC 51414-501. Our review revealed that the listing for this product includes inaccurate information. You have failed to address this listing deficiency detailed in FDA’s letter to your company on January 18, 2018. A data removal notification was also sent to your company on March 5, 2018 and at that time, the listing data was removed from the on-line NDC Directory. Prompt action must be taken to correct this deficiency.

Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) outlines the requirements for registration and listing of drug products. For Mouth Fresh, NDC 51414-501, the listing must include “the label and package insert for such drug . . . .”^{^[1]}

A review of Mouth Fresh, NDC 51414-501, reveals that the product’s listing includes an incorrect copy of the carton label. The image uploaded into the FDA’s Electronic Drug Registration and Listing System (eDRLS) does not appear to be an image of your listed product’s label. Specifically, the carton label included refers to Antibacterial Wet Wipes with benzalkonium chloride 0.13% as the active ingredient, while the product listed in the electronic listing refers to Mouth Fresh Spray, with cetylpyridinium chloride 0.05% as the active ingredient.

Your firm failed to fulfill its listing obligations under Section 510(j) of the FD&C Act, which is a prohibited act under Section 301(p) (21 U.S.C. 360[j] and 331[p]). In addition, your firm’s failure to fulfill its listing obligations misbrands the product under Section 502(o) of the FD&C Act; introduction or delivery for introduction into interstate commerce of a misbranded product is a prohibited act under Section 301(a) (21 U.S.C. 352[o] and 331[a]).

This information must be corrected to ensure its accuracy. Information from your firm’s registration and product listing are accessible not only to FDA, but to other interested parties, including consumers. Your product’s listing information has been removed from the FDA’s Online NDC Directory and will not be available for public viewing until the corrections are made. This is an effort to maintain a correct and accurate database to protect and promote the public health.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct this violation. Your response should include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete these corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at edrls@fda.hhs.gov for further assistance. Include the case identification number of 1271, on all correspondence.

Your reply should be sent to:

Tasneem Hussain Pharm. D.

eDRLS Team

Food and Drug Administration

Mail Stop HFD-300

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

WO 51 and Room # 2261

Finally, you should know that this letter is not intended to be an all-inclusive list of the registration violations found in your firm’s registration and product listing. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the error(s) and bring the product into compliance.

Sincerely,

/S/

Maria Rossana R. Cook

Director

Office of Program and Regulatory Operations

Office of Compliance

Center for Drug Evaluation and Research

cc: APAX International, Inc

Attn: LiaoJames@yahoo.com

[1] See FD&C Act section 510(j)(1)(B)(ii); 21 CFR 207 subpart D.