tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
The Vapor Emporium LLC
MARCS-CMS 613485 —
June 24, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101506
Product:
Tobacco
Recipient:
Recipient Name
Deana Kirkpatrick
The Vapor Emporium LLC
United States
deana@thevaporemporium.com
Issuing Office:
Center for Tobacco Products
United States
Dear Deana Kirkpatrick:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your Warning Letter response emails dated March 19, 2021 and April 12, 2021, in response to our Warning Letter dated February 26, 2021. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter regarding your website https://www.thevaporemporium.com.
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 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.
Sincerely,
/S/
Mallory Johnson
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Domains By Proxy, LLC
thevaporemporium.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
07/19/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
The Vapor Island Inc.
MARCS-CMS 610371 —
June 29, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001439
Product:
Tobacco
Recipient:
Recipient Name
David Kobel and Tanja Thompson
The Vapor Island Inc.
1890 N Tamiami Trail Ste D2
North Fort Myers
,
FL
33903
United States
orders@thevaporisland.com
vaporisland@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear David Kobel and Tanja Thompson:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated August 27, 2020. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.thevaporisland.com.
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 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.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
David Kobel and Tanja Thompson
3713. N.E. 12th Place
Cape Coral, FL 33909
GoDaddy.com, LLC
abuse@godaddy.com
EIG Network Operations
abuse@hostgator.com
Content current as of:
07/19/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
The Vapor Spot, LLC
MARCS-CMS 613225 —
July 01, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101490
Product:
Tobacco
Recipient:
Recipient Name
John Jenkins
The Vapor Spot, LLC
United States
thevaporspot@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear John Jenkins:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your email dated February 26, 2021, in response to our Warning Letter dated February 12, 2021. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter regarding the website, https://www.thevaporspot.com.
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 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.
Sincerely,
/S/
Mallory Bowling
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Domain Privacy Service FBO Registrant
thevaporspot.com@domainprivacygroup.com
Domain.com, LLC
compliance@domain-inc.net
InMotion Hosting, Inc.
abuse@inmotionhosting.com
Content current as of:
07/07/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapors Gold LLC
MARCS-CMS 614075 —
July 09, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101558
Product:
Tobacco
Recipient:
Recipient Name
Mark West
Vapors Gold LLC
United States
mark@vaporsgold.com
Issuing Office:
Center for Tobacco Products
United States
Dear Mark West:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your response dated May 6, 2021, in response to our Warning Letter dated March 26, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding the website https://vaporsgold.com.
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 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.
Sincerely,
/S/
Nathan Everly
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
cc:
Vapor’s Gold LLC
Attn: Mark West
vaporsgold.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Wix.com Inc.
abuse@hostway.com
Content current as of:
09/28/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Ventura Foods LLC
MARCS-CMS 609201 —
September 22, 2021
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Staci Smith
Recipient Title
Vice President Food Safety and Quality Systems
Ventura Foods LLC
40 Pointe Dr.
Brea
,
CA
92821
United States
ssmith@veturafoods.com
Issuing Office:
Division of Human and Animal Food Operations East V
United States
(513) 679-2700
Dear Ms. Smith:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter 609201, dated October 28, 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 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:
09/28/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Village Pharmacy
MARCS-CMS 516174 —
February 01, 2021
Delivery Method:
Electronic Email
Reference #:
#17-NWJ-10
Product:
Drugs
Recipient:
Recipient Name
Ann Ervin
Recipient Title
Owner
Village Pharmacy
1280 Yardville-Allentown Road
Allentown
,
NJ
08501-1830
United States
ann@thevillagepharmacy.com
Issuing Office:
New Jersey District Office
United States
(973) 331-4900
Dear Ms. Ervin:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #17-NWJ-10, dated October 30, 2017. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Diana Amador-Toro
Program Division Director/District Director
Office of Pharmaceutical Quality Operations
Division I/New Jersey District Office
Content current as of:
02/12/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Voltage Vapor Shop LLC
MARCS-CMS 614010 —
July 09, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101560
Product:
Tobacco
Recipient:
Recipient Name
Chase Calloway
Voltage Vapor Shop LLC
United States
voltagevaporshop@gmail.com
sales@voltagevaporshop.com
voltagevaporshop2@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Chase Calloway:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions in your responses dated March 26, 2021 and April 14, 2021 in response to our Warning Letter dated March 26, 2021. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter regarding the website https://voltagevaporshop.com.
However, our surveillance shows you continue to offer for sale to customers in the United States other tobacco products that may be subject to market authorization requirements. FDA encourages you to discuss with your suppliers the current status of any particular tobacco product’s marketing application or any product’s marketing authorization. For additional information regarding currently marketed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement, please visit our website
https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-lists?utm_medium=email&utm_source=govdelivery#list%20of%20deemed
.
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 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.
Sincerely,
/S/
Nathan Everly
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Voltage Vapor Shop LLC
Attn: Chase Calloway
voltagevaporshop.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc
abuse@shopify.com
Content current as of:
07/20/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Wewoka Animal Hospital
MARCS-CMS 577595 —
June 24, 2021
Delivery Method:
UPS Overnight
Product:
Animal & Veterinary
Recipient:
Recipient Name
Dr. Rory G. Stricklin
Wewoka Animal Hospital
Robie Watters
12821 Ns 3650
Wewoka
,
OK
74884
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Secondary Issuing Offices
United States
Dear Dr. Rory G. Stricklin:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #577595, dated June 3, 2019) issued following an inspection of your Wewonka Animal Hospital located at 12821 Ns 3650, Wewoka, Oklahoma 74884. 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/
Jessica E. Havranek
Director, Compliance Branch
Human & Animal Food Operations, WD3
Content current as of:
12/15/2023
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Whitsons Food Service - Bronx, Corp.
MARCS-CMS 572255 —
November 01, 2021
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Paul J. Whitcomb
Recipient Title
President and Chief Executive Officer
Whitsons Food Service - Bronx, Corp.
1800 Motor Parkway
Islandia
,
NY
11749
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Dear Mr. Whitcomb:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS 572255, August 9, 2019]. 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/
CDR Catherine M. Beer
Director of Compliance
Office of Human and Animal Food Operations
East – Division 1
Content current as of:
11/10/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Wicks & Wires Vape Shoppe
MARCS-CMS 605745 —
June 29, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2001279
Product:
Tobacco
Recipient:
Recipient Name
Joseph Pirrota
Wicks & Wires Vape Shoppe
United States
support@wicksandwires.com
joe@wicksandwires.com
Issuing Office:
Center for Tobacco Products
United States
Dear Joseph Pirrota:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your responses dated April 1, 2020 and April 23, 2020 in response to our Warning Letter dated March 27, 2020. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.wicksandwires.com.
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 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.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Domains By Proxy, LLC
wicksandwires.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
07/07/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Winter Gardens Quality Foods, Inc.
MARCS-CMS 608240 —
October 01, 2021
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Thomas M. Bross
Recipient Title
Chief Executive Officer
Winter Gardens Quality Foods, Inc.
304 Commerce St.
New Oxford
,
PA
17350-1723
United States
tbross4@wintergardens.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Thomas M. Bross,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter with CMS #608240, dated August 5, 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 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/
Daniel W. Johnson
Compliance Officer
HAF Division East 2, Philadelphia Office
Office p hone: 215.717.3746
e-mail: Daniel.Johnson@fda.hhs.gov
Cc (via email):
Randy F. Pack, Program Division Director, District Director (randy.pack@fda.hhs.gov)
Robin M. Rivers, Director, Compliance Branch (Robin.Rivers@fda.hhs.gov)
Martin J. Guardia, Director, Investigations Branch (martin.guardia@fda.hhs.gov)
Margaret E. DiGennaro, Supervisory Consumer Safety Officer (Margaret.DiGennaro@fda.hhs.gov)
Content current as of:
10/08/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
World Packaging Solutions, LLC
MARCS-CMS 612824 —
September 27, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Jim Sonsalla
World Packaging Solutions, LLC
3901 NW 79th Ave
Suite 245-1468
Miami
,
FL
33166
United States
js@wpkgs-ppe.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Sonsalla:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 612824, June 28, 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 yours,
/S/
Donna Engleman, MS, BSN
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
10/07/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Yuki Gosei Kogyo Co., Ltd.
MARCS-CMS 547871 —
November 16, 2021
Reference #:
320-18-63
Product:
Drugs
Recipient:
Recipient Name
Mr. Makoto Kito, Ph.D.
Recipient Title
General Manager
Yuki Gosei Kogyo Co., Ltd.
Joban Factory
788, Ochiai, Joban Nishigo-machi
Iwaki-shi
,
Fukushima
972-8316
Japan
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Kito:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-18-63 dated July 17, 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
Compliance Officer
Division of Drug Quality I
Content current as of:
11/29/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Zhejiang Huahai Pharmaceutical
MARCS-CMS 566685 —
November 04, 2021
Product:
Drugs
Recipient:
Recipient Name
Mr. Baohua Chen
Recipient Title
Chairman and President
Zhejiang Huahai Pharmaceutical
Xunqiao Xin Street
Linhai Shi
Taizhou Shi
Zhejiang Sheng
,
317024
China
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Chen:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-04 dated November 29, 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/
Rory K. Geyer
Compliance Officer
Division of Drug Quality II
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research FDA
Content current as of:
11/10/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
10057223 Canada Inc. dba Maddog Juice
MARCS-CMS 620717 —
June 10, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101672
Product:
Tobacco
Recipient:
Recipient Name
David Di Lallo
10057223 Canada Inc. dba Maddog Juice
United States
Issuing Office:
Center for Tobacco Products
United States
Dear David Di Lallo:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your response dated April 13, 2022 to our Warning Letter dated November 5, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.maddogjuice.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation 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 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Attn: Tennille Redding
tennille@maddogjuice.com
eNom, LLC
abuse@enom.com
InMotion Hosting, Inc.
abuse@inmotionhosting.com
Content current as of:
06/24/2022
Regulated Product(s)
Tobacco