tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Cantoro Food Market
MARCS-CMS 635063 —
March 27, 2023
Product:
Food & Beverages
Recipient:
Recipient Name
Michael A. Fallone
Cantoro Food Market
15550 N Haggerty Rd.
Plymouth
,
MI
48170-4892
United States
Issuing Office:
Division of Northern Border Imports
United States
Dear Michael A. Fallone:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS 635063 dated July 21, 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/
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:
04/04/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Cantronic Systems Inc.
MARCS-CMS 613542 —
July 20, 2023
Product:
Medical Devices
Recipient:
Recipient Name
James Zahn
Recipient Title
Chief Executive Officer
Cantronic Systems Inc.
#8-62 Fawcett Rd
Coquitlam
BC
V3K 6V5
Canada
james.zhan@cantronics.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear James Zahn:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613542, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.
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 in the future.
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:
Dallas Thomas
FDAbasics LLC
15815 SW 11th Court Road
Ocala, FL 34473
dallas@fdabasics.com
Content current as of:
07/25/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Celletech, Ltd
MARCS-CMS 525396 —
May 05, 2023
Product:
Dietary Supplements
Recipient:
Recipient Name
Temple E. Palmer
Recipient Title
Owner
Celletech, Ltd
518 Tasman Street
Suite B
Madison
,
WI
53714-3100
United States
Issuing Office:
Minneapolis District Office
United States
Dear Ms. Palmer:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated August 28, 2018. 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:
05/08/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Centurion Medical Products Corporation
MARCS-CMS 598837 —
May 01, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Vishwanath Bhave
Recipient Title
Medline Divisional President
Centurion Medical Products Corporation
Three Lakes Drive
Northfield
,
IL
60093
United States
Issuing Office:
Division of Medical Device and Radiological Health Operations East
United States
Dear Mr. Bhave:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated June 11, 2020 (WL # 598837). 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/
Gina Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health, Division 1
U.S. Food and Drug Administration
Cc: Karen Kowalczyk, Sr Dir QA Quality, Medline Industries, LP, KKowalczyk@medline.com
Content current as of:
05/08/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
CHS Inc./CHS River Plains
MARCS-CMS 642790 —
August 08, 2023
Product:
Animal & Veterinary
Recipient:
Recipient Name
Jay Debertin
Recipient Title
President and CEO
CHS Inc./CHS River Plains
5500 Cenex Drive
Inver Grove Heights
,
MN
55077
United States
Issuing Office:
Division of Human and Animal Food Operations West I
United States
Dear Mr. Debertin:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter MIN CMS 642790 dated November 30, 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/
Dianna C. Sonnenburg, MPH
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
cc: Chad A. VanderLaan
Location Manager
CHS River Plains
998 E. Main Street
Strasburg, ND 58573-0437
Content current as of:
08/23/2023
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Chula Vista Imports Ltd.
MARCS-CMS 614758 —
February 14, 2023
Product:
Food & Beverages
Recipient:
Recipient Name
J. Trinidad Sandoval
Recipient Title
Owner
Chula Vista Imports Ltd.
2541 S. Damen Ave Unit A
Chicago
,
IL
60608-5206
United States
Issuing Office:
Division of Northern Border Imports
United States
Dear J. Trinidad Sandoval:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS 614758 dated September 8, 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
Cloud X Vapes Forest Lake LLC d/b/a CloudXVapes
MARCS-CMS 644225 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2200718
Product:
Tobacco
Recipient:
Recipient Name
Jessie K. Shocinski
Cloud X Vapes Forest Lake LLC d/b/a CloudXVapes
United States
cloudxvapes@hotmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Jessie K. Shocinski:
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 November 3, 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:
09/09/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Comasphere LLC
MARCS-CMS 581207 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2000037
Product:
Tobacco
Recipient:
Recipient Name
Justin M. Roseman
Comasphere LLC
United States
admin@comasphere.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Justin Roseman:
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 19, 2020 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:
09/09/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Cosmax Nbt Usa, Inc.
MARCS-CMS 615933 —
November 30, 2023
Delivery Method:
UPS Overnight
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Jay Ahn
Recipient Title
CEO
Cosmax Nbt Usa, Inc.
3366 Miller Park S
Garland
,
TX
75042-7771
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Dear Mr. Ahn:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 615933 dated May 03, 2023) issued following an inspection of your beverage manufacturing and distribution facility, located at 3350 Marquis Dr., Garland, TX 75042-7771. 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,
West Division 3
Content current as of:
12/05/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Cosmax USA, Inc.
MARCS-CMS 606909 —
March 01, 2023
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Mr. Byung-Joo Lee
Recipient Title
Chief Operation Officer
Cosmax USA, Inc.
105 Challenger Road
9th Floor
Ridgefield Park
,
NJ
07660
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
Dear Mr. Lee:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [#606909 dated October 15, 2020]. 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/
Nicholas F. Lyons
Director of Compliance
Division of Pharmaceutical Quality Operations III
Content current as of:
03/13/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
CreativeStar Solutions
MARCS-CMS 613535 —
July 20, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Steven Gao
Recipient Title
President
CreativeStar Solutions
1601 Trapelo Road
Suite 260
Waltham
,
MA
02451
United States
steven.gao@cssinco.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Steven Gao:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613535, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.
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 in the future.
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
Content current as of:
07/24/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
CTX Lifesciences Private Ltd.
MARCS-CMS 577416 —
January 11, 2023
Product:
Drugs
Recipient:
Recipient Name
Mr. Kanak J. Jariwala
Recipient Title
Managing Director
CTX Lifesciences Private Ltd.
Block No. 251-252, Sachin Magdalla Road
GIDC
Sachin, Surat
394230
Gujarat
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Jariwala:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-30 dated July 12, 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/
Christina Alemu-Cruickshank
Compliance Officer
Division of Drug Quality I
Content current as of:
01/18/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Custom Vapes
MARCS-CMS 614558 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100124
Product:
Tobacco
Recipient:
Recipient Name
Robyn L. Olive
Custom Vapes
United States
robynolive@gmail.com
scottolive@bellsouth.net
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Robyn L. Olive:
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 6, 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:
09/09/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Custom Vapors Inc d/b/a VIP Custom Vapors/Premier Vape
MARCS-CMS 615203 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100146
Product:
Tobacco
Recipient:
Recipient Name
Randy Sharpe
Custom Vapors Inc d/b/a VIP Custom Vapors/Premier Vape
United States
Premiervape716@gmail.com
bloodinklifelove@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Randy Sharpe:
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 June 23, 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
VIA Electronic Mail
cc:
Randysharpe1@outlook.com
Content current as of:
09/20/2024
Regulated Product(s)
Tobacco