tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Tropical Bakery Wholesale Corp.
MARCS-CMS 598858 —
July 28, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
23-HAFE4-WLCOL-04
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Harold Mir
Recipient Title
President
Tropical Bakery Wholesale Corp.
2460 West 1st Avenue
Hialeah
,
FL
33010-1718
United States
Bakerycorp100@gmail.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Dear Mr. Mir:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 20-HAFE4-WL-05 dated February 26, 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/
Pearl E. Lopina -S
Pearl Lopina
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
08/04/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Turncoat Industries, Inc.
MARCS-CMS 623002 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101698
Product:
Tobacco
Recipient:
Recipient Name
Khaled Aboabdo
Turncoat Industries, Inc.
United States
cal@shopjohnnyapple.com
turncoatlabs@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Khaled Aboabdo:
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 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, 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:
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc
abuse@shopify.com
Content current as of:
09/18/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Ulrich Farms
MARCS-CMS 622336 —
May 24, 2023
Product:
Animal & Veterinary
Recipient:
Recipient Name
Justin M. Ulrich, Jake Ulrich, Corey Ulrich
Recipient Title
Co-owners
Ulrich Farms
950 – 180th Street
Dresser
,
WI
54009-4624
United States
Issuing Office:
Division of Human and Animal Food Operations West I
United States
Dear Messrs Ulrich:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 622336 dated February 7, 2022. 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/
Boun M. Xiong
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
05/31/2023
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Unimicro Medical Systems Shenzhen Co., Ltd.
MARCS-CMS 624560 —
May 18, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Roly Lee
Recipient Title
General Manager and Co-Founder
Unimicro Medical Systems Shenzhen Co., Ltd.
201, Bldg 38 101 Heshui Kou
Gongmingzhen Longgang
Shenzhen
518106
China
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Roly Lee:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #624560 dated 01/06/2022. 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 yours,
/S/
Courtney H. Lias, Ph.D.
Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Zeyu Chen
238 Fernwood Ave, Edison, New Jersey 08837
Content current as of:
05/31/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
University Fertility Laboratory, Inc.
MARCS-CMS 577584 —
August 03, 2023
Delivery Method:
Via Email
Product:
Biologics
Recipient:
Recipient Name
Dr. Omid A. Khorram
Recipient Title
Medical Director
University Fertility Laboratory, Inc.
23550 Hawthorne Blvd., Suite 210
Torrance
,
CA
90505
United States
okhorram@yahoo.com
Issuing Office:
Division of Biological Products Operations II
United States
Dear Dr. Khorram:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter # OBPO 19-006 issued May 30, 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/
Amy Graf
Compliance Officer
Content current as of:
08/10/2023
Regulated Product(s)
Biologics
CLOSEOUT LETTER
USA Medical LLC
MARCS-CMS 631500 —
February 06, 2023
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Damon Roberts
Recipient Title
President/Owner
USA Medical LLC
1220 Texan Trail
Suite 205
Grapevine
,
TX
76051-4164
United States
damon@usamedicalllc.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Roberts,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to Warning Letter #631500 dated 8/3/2022. 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
Compliance Branch Director
Office of Medical Devices and Radiological Health Operations
Division 3/West
Content current as of:
02/09/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Valley View Milling LLC
MARCS-CMS 626198 —
September 29, 2023
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mark C. Haverkamp
Recipient Title
Owner
Valley View Milling LLC
2875 State Highway 63
Seneca
,
KS
66538-2145
United States
Issuing Office:
Office of Human and Animal Food- West Division II
United States
Dear Mr. Haverkamp,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS 626198 dated May 17, 2022. 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/
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Foods, Division West II
Content current as of:
10/10/2023
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
The Vape Bar LLC d/b/a The Vape and More LLC
MARCS-CMS 622851 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100367
Product:
Tobacco
Recipient:
Recipient Name
Fash Fadaei
The Vape Bar LLC d/b/a The Vape and More LLC
United States
fash@thevapebar.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Fash Fadaei:
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 16, 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:
Joanna.kay129@icloud.com
Content current as of:
09/09/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapeoholic LLC
MARCS-CMS 613226 —
December 01, 2023
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2101498
Product:
Tobacco
Recipient:
Recipient Name
Vincent Roxas
Vapeoholic LLC
United States
vapeoholiclosangeles@gmail.com
sales@www.vapeoholic.com
returns@www.vapeoholic.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Vincent Roxas:
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 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:
GoDaddy.com, LLC
abuse@godaddy.com
InMotion Hosting, Inc
abuse@inmotionhosting.com
Content current as of:
09/18/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapeoholic LLC
MARCS-CMS 642583 —
December 01, 2023
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2201858
Product:
Tobacco
Recipient:
Recipient Name
Vincent Jay A. Roxas
Vapeoholic LLC
United States
returns@www.vapeoholic.com
sales@www.vapeoholic.com
vapeoholiclosangeles@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Vincent Jay A. Roxas:
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 September 22, 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
VIA Electronic Mail
cc:
GoDaddy.com, LLC
abuse@godaddy.com
InMotion Hosting, Inc.
abuse@inmotionhosting.com
Content current as of:
09/18/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapes Gone Wild Juice, LLC
MARCS-CMS 613227 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101497
Product:
Tobacco
Recipient:
Recipient Name
Trent Struck
Vapes Gone Wild Juice, LLC
United States
vapesgonewild@gmail.com
info@vapesgonewild.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Trent Struck:
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 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:
ENOM, INC.
abuse@enom.com
Google LLC
Google-cloud-compliance@google.com
Content current as of:
09/19/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapor Arts LLC d/b/a Main Street Vapor Co.
MARCS-CMS 629908 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2200512
Product:
Tobacco
Recipient:
Recipient Name
Shalonda Lowther
Vapor Arts LLC d/b/a Main Street Vapor Co.
United States
msvapeco@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Shalonda Lowther:
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 18, 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
VIA Electronic Mail
cc:
Shalonda.Lowther@gmail.com
Content current as of:
09/13/2024
Regulated Product(s)
Tobacco