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  5. Shijin Vapor, LLC - 620155 - 12/01/2023
  1. Warning Letters

CLOSEOUT LETTER

Shijin Vapor, LLC MARCS-CMS 620155 —

Delivery Method:
VIA Electronic Mail
Reference #:
ER2100299
Product:
Tobacco
Recipient:
Recipient Name
Tony Doan
Shijin Vapor, LLC

United States

tony@shijinvapor.com
Issuing Office:
Center for Tobacco Products

United States

Secondary Issuing Offices

United States

Dear Tony Doan:

The United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has completed evaluation of your corrective actions in response to FDA’s November 9, 2021 Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violations contained in the 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 ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.

It is your responsibility to ensure that all of your tobacco products and all related labeling and/or advertising on any websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.

If you have any questions, please contact CTPCompliance@fda.hhs.gov.


Sincerely,
/s/
Chad Burger
Director
Division of Product Compliance
Office of Compliance and Enforcement
Center for Tobacco Products

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