tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Vapor Cigs LLC
MARCS-CMS 613742 —
December 14, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101539
Product:
Tobacco
Recipient:
Recipient Name
Gregory Carr
Vapor Cigs LLC
United States
greg8401@yahoo.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Gregory Carr:
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 March 12, 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
VIA Electronic Mail
cc:
Wild West Domains, LLC
abuse@wildwestdomains.com
A2 Hosting, Inc.
abuse@a2hosting.com
Content current as of:
09/19/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
The Vaporatory, LLC
MARCS-CMS 613506 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101517
Product:
Tobacco
Recipient:
Recipient Name
Evan Fels
The Vaporatory, LLC
United States
sales@thevaporatory.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Evan Fels:
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 February 26, 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
VIA Electronic Mail
cc:
Domains By Proxy, LLC
thevaporatory.com@domainsbyproxy.com
GoDaddy, LLC
abuse@godaddy.com
Shopify Inc.
abuse@shopify.com
Content current as of:
09/18/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapors of Alabama Jasper
MARCS-CMS 624054 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100407
Product:
Tobacco
Recipient:
Recipient Name
Charles Black
Vapors of Alabama Jasper
United States
vaporsinc2@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Charles Black:
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 February 17, 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:
09/19/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapors Inc. d/b/a Vapors of Alabama Gardendale
MARCS-CMS 624614 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2200431
Product:
Tobacco
Recipient:
Recipient Name
Keith Aldijaili
Vapors Inc. d/b/a Vapors of Alabama Gardendale
United States
vaporsinc2@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Keith Aldijaili:
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 February 17, 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:
09/19/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapors Inc. d/b/a Vapors of Alabama Oneonta
MARCS-CMS 623620 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100401
Product:
Tobacco
Recipient:
Recipient Name
Charles Black
Vapors Inc. d/b/a Vapors of Alabama Oneonta
United States
vaporsinc2@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Charles Black:
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 February 17, 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:
09/19/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Victory Vapor
MARCS-CMS 619695 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100285
Product:
Tobacco
Recipient:
Recipient Name
John Key
Victory Vapor
United States
Victoryvapor2@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear John Key:
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 December 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
Content current as of:
09/20/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vital Health & Wellness
MARCS-CMS 618743 —
April 28, 2023
Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Christopher A. Williamson
Recipient Title
Owner
Vital Health & Wellness
800 Industrial Park Dr.
Trenton
,
TN
38382
United States
officevitaltea@gmail.com
Issuing Office:
Office of Human and Animal Foods Operations-East V
United States
Dear Mr. Williamson:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter 618743, dated February 17, 2022. Based on our evaluation, it appears that you have addressed the violation(s) contained in this 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 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 will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Christopher N. Dedeaux
Compliance Officer
Office of Human and Animal Foods Operations
Division 5 East
Content current as of:
05/08/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
WHPM Inc.
MARCS-CMS 629146 —
March 03, 2023
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Dr. John Wan
Recipient Title
CEO & President
WHPM Inc.
5358 Irwindale Ave.
Ste. B
Irwindale
,
CA
91706
United States
johnwan@whpm.com
Issuing Office:
Office of Medical Device and Radiological Health Division 3
United States
Dear Dr.Wan:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #629146) dated June 30, 2022. Based on our evaluation, it appears that you
have addressed the violation(s) contained in this 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 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 will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Jessica Mu
Director, Compliance Branch
Office of Medical Device and Radiological Health Operations
Division 3
Content current as of:
03/13/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
YemenUSA Inc.
MARCS-CMS 615141 —
February 14, 2023
Product:
Food & Beverages
Recipient:
Recipient Name
Sami Alsulaimani
Recipient Title
Owner President
YemenUSA Inc.
8864 Greenfield Road
Detroit
,
MI
48228-2237
United States
Issuing Office:
Division of Northern Border Imports
United States
Dear Sami Alsulaimani:
The Food and Drug Administration has completed an evaluation of YemenUSA Inc’s corrective actions in response to our Warning Letter CMS# 615141 dated July 22, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this 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 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 will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Sherea L. Dillon
Director of Compliance
Division of Northern Border Imports
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
02/24/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Abbott Laboratories
MARCS-CMS 669353 —
December 12, 2024
Product:
Biologics
Recipient:
Recipient Name
Robert B. Ford
Recipient Title
CEO
Abbott Laboratories
100 Abbott Park Road
Abbott Park
,
IL
60064
United States
robert.ford@abbott.com
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Secondary Issuing Offices
United States
Dear Mr. Ford:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to Warning Letter (WL) #669353 dated 10/24/2023. Based on our evaluation, we understand you are no longer marketing Similac® Probiotic Tri-Blend; as such, it appears that you have addressed the violations contained in this WL. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
We acknowledge, based on information we received after issuance of the WL, that
Bifidobacterium longum
subsp.
infantis
DSM 33361 (BB-02) is a dietary ingredient according to section 201(ff)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). We note, however, that our evaluation also concludes that a dietary supplement containing BB-02 presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling when the product is recommended or suggested in the labeling for use by preterm infants [see sec 402(f)(1)(A) of the FD&C Act].
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 will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Lawlor, Branch Chief
Dietary Supplement Enforcement Branch
Division of Critical Foods and Dietary
Supplement Enforcement
Office of Enforcement
Office of Compliance and Enforcement
Content current as of:
01/21/2025
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Abraxis Bioscience LLC
MARCS-CMS 633713 —
January 18, 2024
Reference #:
FEI 3006441852
Product:
Drugs
Recipient:
Recipient Name
Nathan Trembath
Recipient Title
General Manager
Abraxis Bioscience LLC
620 N 51 St. Ave.
Phoenix
,
AZ
85043
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
Dear Mr. Trembath:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 633713 dated October 31, 2022.
Based on our evaluation, it appears that you have addressed the violation contained in this 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 assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.
The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Joan Johnson
Compliance Officer
Division of Drug Quality I
Content current as of:
03/25/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Allure Foods LLC
MARCS-CMS 625478 —
December 02, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Motty Zablotsky
Recipient Title
President
Allure Foods LLC
1833 63rd St.
Brooklyn
,
NY
11204-2933
United States
Issuing Office:
Division of Northeast Imports
United States
Secondary Issuing Offices
United States
Dear Mr. Zablotsky:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 625478 dated April 24, 2022. Based on our evaluation, it appears that you have addressed the violation contained in this 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 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 will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
Anna Alexander
Director, Compliance Branch
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration
Content current as of:
12/06/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Aspen Sales Group
MARCS-CMS 609365 —
December 05, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Laurie Bogle
Recipient Title
CFO
Aspen Sales Group
350 Main St., Suite 6A
Bedminster
,
NJ
07921-2603
United States
Issuing Office:
Division of Northeast Imports
United States
Secondary Issuing Offices
United States
Dear Ms. Bogle,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 609365 dated October 07, 2020. Based on our evaluation, it appears that you have addressed the violation contained in this 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 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 will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Anna Alexander
Director, Compliance Branch
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration
Content current as of:
12/12/2024
Regulated Product(s)
Food & Beverages