FDA Letter API

Ragin Vapors

Letter data

Company
Ragin Vapors
Recipient
John Corey Buhler | Ragin Vapors | United States | Corey@raginvapors.com
Issue date
2023-12-01
Posted date
Not available
FDA office
Center for Tobacco Products
Subject
Not available
Product
Tobacco
CMS ID
641871
Reference number
ER2200673
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: 21-CFR-PART-114021-CFR-PART-1141

21 U.S.C.: 21-USC-301

Related FDA links

No related FDA letter link is present in the source index.

Full source text

CLOSEOUT LETTER Ragin Vapors MARCS-CMS 641871 — December 01, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: ER2200673 Product: Tobacco Recipient: Recipient Name John Corey Buhler Ragin Vapors United States Corey@raginvapors.com Issuing Office: Center for Tobacco Products United States Secondary Issuing Offices United States Dear John Corey Buhler: The United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has completed its evaluation of your corrective actions in response to FDA’s October 20, 2022 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 Content current as of: 09/16/2024 Regulated Product(s) Tobacco