tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
International Vaperz LLC d/b/a Vaperz Cedar Park
MARCS-CMS 616659 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100188
Product:
Tobacco
Recipient:
Recipient Name
Stephen Robertson and Connie Robertson
International Vaperz LLC d/b/a Vaperz Cedar Park
United States
steve@vaperztx.com
retail@vaperztx.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Stephen Robertson and Connie Robertson:
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 August 10, 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, no tobacco-sale order 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
Invacare Corporation
MARCS-CMS 617319 —
August 21, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Geoffrey P. Purtill
Recipient Title
President and CEO
Invacare Corporation
One Invacare Way
Elyria
,
OH
44035
United States
gpurtill@invacare.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Geoffrey P. Purtill:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter WL # 617319 dated November 18, 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/
Gina M. Brackett, Director of Compliance
Office of Medical Devices & Radiological Health
Division-1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration
CC: Jason Fiest (VP of Quality and Regulatory Affairs for North America)
Email: jfiest@invacare.com
Content current as of:
08/24/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Jackson Health & Wellness Clinic
MARCS-CMS 646556 —
August 01, 2023
Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
William (Bill) Miller
Recipient Title
Owner
Jackson Health & Wellness Clinic
123 Devonshire Sq, Ste B
Jackson
,
TN
38305
United States
Issuing Office:
Division of Human and Animal Food Operations East V
United States
Dear Mr. Miller:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter 646556, dated February 3, 2023. Based on our evaluation, it appears that you have addressed the violations 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:
08/04/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Jayde’s Vapor Lounge
MARCS-CMS 622098 —
December 14, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100347
Product:
Tobacco
Recipient:
Recipient Name
Jayde Tran
Jayde’s Vapor Lounge
United States
jaydesvaporlounge@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Jayde Tran:
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 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:
09/13/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Jiangsu NHWA Pharmaceutical Co., Ltd.
MARCS-CMS 582511 —
November 17, 2023
Product:
Drugs
Recipient:
Recipient Name
Weibing Wang
Recipient Title
Vice President – Operations
Jiangsu NHWA Pharmaceutical Co., Ltd.
No. 6 Tianyong Road, Industrial Park
Xuzhou, Jiangsu
221000
China
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
Dear Mr. Wang:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-42 dated September 10, 2019.
Based on our evaluation, it appears that you have addressed the deviations 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 deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Rokhsana Safaai-Jazi
Compliance Officer
Division of Drug Quality II
Content current as of:
12/15/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
JJDS E Cigarettes LLC d/b/a TKO Vapor Overstock Ecigs & More
MARCS-CMS 619195 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100276
Product:
Tobacco
Recipient:
Recipient Name
Matt Garcia
JJDS E Cigarettes LLC d/b/a TKO Vapor Overstock Ecigs & More
United States
james@tkovapor.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Matt Garcia:
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 October 15, 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:
09/13/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Jones Affiliated Inc.
MARCS-CMS 639035 —
October 31, 2023
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Henry Jeong
Recipient Title
President/Owner
Jones Affiliated Inc.
17202 Marquardt Ave.
Cerritos
,
CA
90703-1022
United States
henry@modernteaism.com
Issuing Office:
Division of West Coast Imports
United States
Dear Mr. Henry Jeong:
The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated August 23, 2022 (CMS #639035). Based on our evaluation, it appears that you have addressed the violations 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/
Lawton W. Lum
Director of Compliance Branch
Division of West Coast Imports
Content current as of:
11/07/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Juicemafia, Inc. d/b/a Ecig-Works
MARCS-CMS 642933 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2200689
Product:
Tobacco
Recipient:
Recipient Name
Joanne Schemahorn
Juicemafia, Inc. d/b/a Ecig-Works
United States
Juicemafiawholesale@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Joanne Schemahorn:
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 13, 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:
09/13/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
JVS Vapor Inc d/b/a Jacks Vapor
MARCS-CMS 632901 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2200549
Product:
Tobacco
Recipient:
Recipient Name
James Jackson
JVS Vapor Inc d/b/a Jacks Vapor
United States
jvsvaporinc@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear James Jackson:
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 May 25, 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:
09/13/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
K&D Vapors
MARCS-CMS 616094 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100168
Product:
Tobacco
Recipient:
Recipient Name
David Borella
K&D Vapors
United States
kanddvapors@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear David Borella:
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 July 22, 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:
09/13/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Keshava Organics Private Ltd.
MARCS-CMS 540146 —
May 12, 2023
Delivery Method:
Via Email
Reference #:
FEI 3003677831
Product:
Drugs
Recipient:
Recipient Name
Mr. Dinkar K. Raut
Recipient Title
Managing Director
Keshava Organics Private Ltd.
T-97, 98, 99 & 100 MIDC Boisar
Palghar
Tarapur
401506
Maharashtra
India
dkraut@keshavaindia.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Raut:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-18-41 dated March 15, 2018.
Based on our evaluation, it appears that you have addressed the deviations 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 deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Christina Alemu-Cruickshank
Public Health Analyst
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
05/31/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Knobbe Cattle Company Inc.
MARCS-CMS 657009 —
December 21, 2023
Delivery Method:
UPS NEXT DAY DELIVERY
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mr. Patrick S. Knobbe
Recipient Title
President
Knobbe Cattle Company Inc.
1037 C Rd
West Point
,
NE
68788
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
Secondary Issuing Offices
United States
Dear Mr. Knobbe:
The Food and Drug Administration has completed evaluation of Knobbe Cattle Company Inc. corrective actions in response to our Warning Letter (CMS case#: 657009, dated May 31, 2023). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspection 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 action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
LaTonya M. Mitchell, Ph.D.
Program Division Director
Human and Animal Food West 2
Content current as of:
01/19/2024
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Kumar Organic Products Limited
MARCS-CMS 598683 —
July 24, 2023
Reference #:
FEI 3009167769
Product:
Drugs
Recipient:
Recipient Name
Mr. K. K. Singh
Recipient Title
Chairman
Kumar Organic Products Limited
Plot No. 379 Canal Road
Maitri Marg, Village Luna, Taluka Padra District
Vadodara
391440
Gujarat
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Singh:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-34 dated April 23, 2020.
Based on our evaluation, it appears that you have addressed the violations 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 and/or deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Michael Klapal
Compliance Officer
Division of Drug Quality II
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
07/27/2023
Regulated Product(s)
Drugs