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.
Content current as of:
04/30/2019