tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Saffron USA LLC
MARCS-CMS 629821 —
January 09, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
23-HAFE4-WLCOL-01
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Farangis Sedaghat
Recipient Title
Owner
Saffron USA LLC
504 Spring Island Way
Orlando
,
FL
32828
United States
ftsedaghat@yahoo.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Dear Ms. Sedaghat:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 22-HAFE4-WL-07 dated September 23, 2022. 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.
Kind regards,
/S/
Pearl Lopina
Director of Compliance Branch
OHAFO, East Division IV
Content current as of:
01/17/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Samchundang Pharm Co., Ltd.
MARCS-CMS 599255 —
March 07, 2023
Product:
Drugs
Recipient:
Recipient Name
Mr. In-Seok Chun
Recipient Title
Chief Executive Officer
Samchundang Pharm Co., Ltd.
351 Hyoryeong-ro
Seocho-gu
Seoul
06643
South Korea
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. In-Seok Chun:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-35 dated May 13, 2020.
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/
Marisa Heayn
Compliance Officer
Division of Drug Quality II
Content current as of:
03/14/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Shenzhen Sunell Technology Corporation
MARCS-CMS 613563 —
July 20, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Ann Wu
Recipient Title
Chief Executive Officer
Shenzhen Sunell Technology Corporation
4 Aerospace Micromoto Bldg. 2 Floor 5
Shenzhen
China
annwu@sunellsecurity.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Ann Wu:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613563, 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:
07/27/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Shijin Vapor, LLC
MARCS-CMS 620155 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100299
Product:
Tobacco
Recipient:
Recipient Name
Tony Doan
Shijin Vapor, LLC
United States
tony@shijinvapor.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Tony Doan:
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 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:
09/17/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Skin Sheek
MARCS-CMS 612682 —
March 10, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Meredith Dodini Hult
Recipient Title
President
Skin Sheek
4431 W. Spruce Court
Highland
,
UT
84003
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Ms. Hult:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 612682, dated January 28, 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/
For Binita S. Ashar, MD, MBA, FACS
Director Office of Surgical and Infection Control Devices
Center for Devices and Radiological Health
Content current as of:
03/14/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Sonesta Medical AB
MARCS-CMS 667325 —
December 04, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Pelin Sari
Recipient Title
Chief Executive Officer
Sonesta Medical AB
Industrivagen 7
171 48
Solna
Sweden
Pelin.Sari@sonestamedical.se
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Ms. Sari,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS Case No. 667325, dated September 22, 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/
Robert Ochs, Ph.D.
Director
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Cc:
Greg Swanson
U.S. Agent
Emergo Global Representation LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin, Texas 78746
USAgent@UL.com
Mark D. Boesen
mboesen@bslawusa.com
Content current as of:
02/28/2024
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Sooil Development Co., Ltd.
MARCS-CMS 607127 —
February 21, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Jin-Seok Noh
Recipient Title
General Manager of Quality Assurance
Sooil Development Co., Ltd.
Yongin-si
Gyeonggi-do
16922
South Korea
yoonheey@sooil.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Jin-Seok Noh:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 607127, dated April 16, 2020). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Feedback related to the November 28 through December 1, 2022, was provided to you via email on February 9, 2023, 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/
Marianela Perez-Torres, Ph.D.
Acting Director
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Jong Hyun Kim
SOOIL LLC
Jeremy@sooilusa.com
Content current as of:
02/24/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Strides Pharma Science Limited
MARCS-CMS 576722 —
May 23, 2023
Product:
Drugs
Recipient:
Recipient Name
Mr. Arun Kumar
Recipient Title
Executive Chairperson & Managing Director
Strides Pharma Science Limited
Strides House, Bilekahalli
Bannerghatta Road
Bangalore
560076
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Kumar:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-28 dated July 1, 2019.
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 be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Christopher Keating
Compliance Officer
Division of Drug Quality II
Cc: Mr. Dayanand Digamberrao More
DayanandD.More@strides.com
Content current as of:
05/24/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Sunshine Mills, Inc.
MARCS-CMS 618141 —
December 21, 2023
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mr. Alan Bostick
Recipient Title
CEO
Sunshine Mills, Inc.
PO Box 676
Red Bay
,
AL
35582
United States
Issuing Office:
Human and Animal Food East V Compliance Branch (HAFE5-CB)
United States
Secondary Issuing Offices
United States
Dear Mr. Bostick:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter #618141, dated March 7, 2022. Based on our evaluation, it appears that you have addressed 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 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/
Allison C. Hunter
Compliance Officer
Content current as of:
02/02/2024
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Surgenex LLC
MARCS-CMS 615254 —
September 20, 2023
Delivery Method:
Via Email
Product:
Biologics
Recipient:
Recipient Name
Abel R. Bullock/Mark A. Schallenberger
Recipient Title
Chief Executive Officer & Owner/Chief Operations Officer
Surgenex LLC
15444 N 76th Street
Suite 110
Scottsdale
,
AZ
85260
United States
abel.bullock@surgenex.com
mark.schallenberger@surgenex.com
Issuing Office:
Office of Biological Products Operations – Division 2
United States
Dear Messrs. Bullock and Schallenberger:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter # OBPO 21-615254 issued November 15, 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/
Amy Graf
Compliance Officer
Content current as of:
09/29/2023
Regulated Product(s)
Biologics
CLOSEOUT LETTER
The Tender Corporation dba Adventure Ready Brand
MARCS-CMS 599789 —
September 28, 2023
Delivery Method:
ELECTRONIC DELIVERY/READ RECEIPT
Product:
Drugs
Recipient:
Recipient Name
Mr. Christopher Heye
Recipient Title
Chief Executive Officer
The Tender Corporation dba Adventure Ready Brand
994 Industrial Park Road
Littleton
,
NH
03561-3956
United States
cheye@adventurereadybrands.com
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Dear Mr. Heye:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #599789], dated July 23, 2020. Based on our evaluation, it appears that you have adequately 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 during a subsequent inspection or through other means.
Respectfully,
/S/
Lisa Harlan
Acting Program Division Director
U.S. Food and Drug Administration
Office of Pharmaceutical Quality Operations
Division I
cc:
Mr. John Gaulin
Chief Operating Officer
The Tender Corporation dba Adventure Ready Brand 994 Industrial Park Road
Littleton, NH 03561 – 3956
jgaulin@adventurereadybrands.com
Content current as of:
09/29/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
MARCS-CMS 633453 —
May 25, 2023
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Athanasios D. Kailis
Recipient Title
President/CEO/Owner
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
5569 N. Northwest Highway
Chicago
,
IL
60630
United States
PKailis@sweetconnectionbakery.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Dear Mr. Kailis:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY22-HAFE6-WL-06. Based on our evaluation, it appears that you have addressed the violation(s) 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 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/
Kelli Wilkinson LCDR
Director of Compliance
Office of Human and Food Operations
Division East 6
Content current as of:
06/02/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Top Class Ejuice, Inc. d/b/a The Dollar E-Juice Club
MARCS-CMS 639611 —
November 20, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
RW2201715
Product:
Tobacco
Recipient:
Recipient Name
James Kim and Jonathan Lee
Top Class Ejuice, Inc. d/b/a The Dollar E-Juice Club
United States
customersupport@thedollarejuiceclub.com
jon@thedollarejuiceclub.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear James Kim and Jonathan Lee:
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 August 11, 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:
Proxy Protection, LLC
wx5tsl9ssh2hpmj@proxy.dreamhost.com
DreamHost, LLC
domain-abuse@dreamhost.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
09/18/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
TreeHouse Foods, Inc.
MARCS-CMS 620320 —
March 28, 2023
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
TreeHouse Foods, Inc.
Cambridge
,
MD
21613
United States
susan.barclay@treehousefoods.com
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Dear Ms. Barclay,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 620320, dated January 28, 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.
Jessica D. Weber
/S/
Compliance Officer
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
03/31/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Triad Rx, Inc.
MARCS-CMS 569659 —
May 03, 2023
Delivery Method:
Via Electronic Mail Return Confirmation Requested
Product:
Drugs
Recipient:
Recipient Name
Matt McDonald
Recipient Title
Owner
Triad Rx, Inc.
26258 Pollard Rd.
Daphne
,
AL
36526-4250
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
Dear Mr. McDonald:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [WL 569659 Issued February 5, 2019]. We acknowledge that your firm no longer produces sterile drug products.
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/
Ronda R. Loyd-Jones
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
07/05/2023
Regulated Product(s)
Drugs