tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Sunshine International Foods, Inc.
MARCS-CMS 580221 —
February 22, 2021
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Emile S. Maroun
Recipient Title
President
Sunshine International Foods, Inc.
26 Spruce Street
Methuen
,
MA
01844
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Dear Mr. Maroun:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 580221, issued on August 8, 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 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 Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
03/02/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Sweet Springs Valley Water Co., Inc.
MARCS-CMS 513227 —
October 04, 2021
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mabel Y. Cox
Recipient Title
Facility Manager
Sweet Springs Valley Water Co., Inc.
1598 Rowan Rd.
Gap Mills
,
WV
24941-8715
United States
sweetsprings@frontier.com
Issuing Office:
Baltimore District Office
United States
Dear Mabel Cox,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter with CMS#513227, dated March 7, 2017. 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)
Karen S. Anthony, Supervisory Consumer Safety Officer (karen.anthony@fda.hhs.gov)
Content current as of:
10/18/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Tailor Cut Produce Inc.
MARCS-CMS 605078 —
March 04, 2021
Delivery Method:
VIA UPS and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Dawn C. Young
Recipient Title
President
Tailor Cut Produce Inc.
832 Ridgewood Avenue
North Brunswick
,
NJ
08902
United States
tailorcut@aol.com
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Dear Ms. Young,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 605078, dated July 8, 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/
Jessica D. Weber
Compliance Officer
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
Cc (via email):
Randy F. Pack, Program Division Director, District Director (
randy.pack@fda.hhs.gov
)
JoAnn DeClement, State Liaison (
joann.declement@fda.hhs.gov
)
Laishan Liza Lam, Acting Director, Compliance Branch (
laishan.lam@fda.hhs.gov
)
Martin J. Guardia, Director, Investigations Branch (
martin.guardia@fda.hhs.gov
)
Raymond Cheung, Supervisory Consumer Safety Officer (
raymond.cheung@fda.hhs.gov
)
Content current as of:
03/16/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Take Off Corp
MARCS-CMS 613224 —
June 08, 2021
Delivery Method:
UPS and Electronic Mail
Reference #:
RW2101483
Product:
Tobacco
Recipient:
Recipient Name
Ghazi Mustafa
Take Off Corp
3846 Linden Ave.
Dayton
,
OH
45432
United States
ghazi@takeoffeliquid.com
takeoffeliquid@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Ghazi Mustafa:
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 emailed and dated February 25, 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 violations contained in the Warning Letter regarding your website https://takeoffeliquid.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 UPS and Electronic Mail
cc:
Thompson Hine LLP
Attn: Eric Heyer
1919 M Street, N.W., Suite 700
Washington, D.C. 20036-1600
Eric.Heyer@ThompsonHine.com
Take Off Corp
11780 Harbour Light Dr.
North Royalton, OH 44133
Prime Vape & Smoke Shop
primevapeandsmokeshop@gmail.com
Contact Privacy Inc.
Takeoffeliquid.com@contactprivacy.com
Shopify, Inc.
Abuse@Shopify.com
Content current as of:
06/28/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Takeda Pharmaceutical Company Limited
MARCS-CMS 603596 —
October 13, 2021
Delivery Method:
Via Email
Reference #:
3004664162
Product:
Drugs
Recipient:
Recipient Name
Mr. Christophe Weber
Recipient Title
President and CEO
Takeda Pharmaceutical Company Limited
Tokyo Head Office
2-1-1, Nihonbashi-Honcho Chuo-ku
Tokyo
103-8668
Japan
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Weber:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-37 dated June 9, 2020.
Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.
The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
for Rafael Arroyo
Compliance Officer
Division of Drug Quality I
Content current as of:
02/02/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Tally Ho Vapor Tonic LLC
MARCS-CMS 613503 —
June 24, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101520
Product:
Tobacco
Recipient:
Recipient Name
David Boor and Shoaib Iqbal
Tally Ho Vapor Tonic LLC
United States
tallyhovapor@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear David Boor and Shoaib Iqbal:
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 email dated March 10, 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 violations contained in the Warning Letter regarding your website https://tallyhovaportonic.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:
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
07/21/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
TP. Food Canning Ltd., Part.
MARCS-CMS 599159 —
April 20, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Paisit Jittasirinuwat
Recipient Title
General Manager/Owner
TP. Food Canning Ltd., Part.
72 Moo 3 Tambol Mae Hia
Klong-Cholpratan Rd.
Chiang Mai
50100
Thailand
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Jittasirinuwat:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 599159, issued 1/22/2020. Based on our evaluation, it appears 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/
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
Content current as of:
05/12/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Tris Pharma Inc.
MARCS-CMS 534537 —
December 27, 2021
Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs
Recipient:
Recipient Name
Mr. Ketan Mehta
Recipient Title
President and CEO
Tris Pharma Inc.
2033 US Highway 130
Suie D
Monmouth Junction
,
NJ
08852
United States
Issuing Office:
New Jersey District Office
United States
Dear Mr. Mehta:
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 # 534537) dated March 26, 2018. 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/
Diana Amador-Toro
Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District
Content current as of:
01/14/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
U.F.S. Industries, Inc. d.b.a. Sally Sherman Foods
MARCS-CMS 580946 —
March 31, 2021
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Felix Endico/Mr. William Endico
Recipient Title
Owner
U.F.S. Industries, Inc. d.b.a. Sally Sherman Foods
300 N. MacQuesten Pkwy
Mount Vernon
,
NY
10550-1008
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 1
United States
Dear Messrs. Endico:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 580946, issued on July 30, 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 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 Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
04/06/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Valentus, Inc.
MARCS-CMS 609611 —
July 23, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Dave Jordan
Recipient Title
Owner
Valentus, Inc.
3900 W. 53rd Street
Sioux Falls
,
SD
57106-4220
United States
Issuing Office:
Division of Human and Animal Food Operations West I
United States
(612) 334-4100
Dear Mr. Jordan:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated November 30, 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/
Carolyn A. Warren
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
07/30/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Valley Proteins, Inc.
MARCS-CMS 582508 —
September 23, 2021
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Curtis R. Robbins
Recipient Title
General Manager
Valley Proteins, Inc.
1635 Indian Hollow Road
Winchester
,
VA
22604-2586
United States
crobbins@valleyproteins.com
Issuing Office:
Division of Human and Animal Food Operations East II (HAFE2)
United States
410-779-5407
jessica.weber@fda.hhs.gov
Dear Mr. Robbins,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 582508, dated November 22, 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 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 D. Weber
Compliance Officer
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
T:
410-779-5407
M:
443-280-1276
jessica.weber@fda.hhs.gov
Cc (via email):
Firm:
Joan Kasprzycki-Strass, Quality Assurance Manager
(
jkasprzyckistrauss@valleyproteins.com
)
FDA:
Randy F. Pack, Program Division Director, District Director (
randy.pack@fda.hhs.gov
)
Natasha DeZinna, State Liaison (
natasha.dezinna@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 Torres-Vazquez, Supervisory Consumer Safety Officer (
margaret.torres-vazquez@fda.hhs.gov
)
Content current as of:
09/28/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
The Vape Corner, Inc.
MARCS-CMS 613522 —
June 24, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101509
Product:
Tobacco
Recipient:
Recipient Name
Gino Sugapong
The Vape Corner, Inc.
United States
info@thevapecorner.com
Issuing Office:
Center for Tobacco Products
United States
Dear Mr. Gino Sugapong:
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 March 18, 2021 and April 13, 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 violations contained in the Warning Letter regarding your website https://www.thevapecorner.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/
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
thevapecorner.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
DigitalOcean, LLC
abuse@digitalocean.com
Content current as of:
07/09/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vape Deal, LLC
MARCS-CMS 608452 —
June 25, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001357
Product:
Tobacco
Recipient:
Recipient Name
Meklek Suna Sarsilmaz Gol
Vape Deal, LLC
5700 Braxton Drive
Ste 100
Houston
,
TX
77036-2125
United States
support@vapedeal.com
Issuing Office:
Center for Tobacco Products
United States
Dear Meklek Suna Sarsilmaz Gol:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated July 20, 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.vapedeal.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:
Vape Deal, LLC
Attn: Meklek Suna Sarsilmaz Gol
3006 Chenevert St.
Houston, TX 77004
Attn: Vapedeal, LLC
wtzf7nhrmkrf9j4t3@proxyregistrant.email
GoDaddy.com, LLC
abuse@godaddy.com
Cloudflare, Inc.
abuse@cloudflare.com
Content current as of:
07/06/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vaping Xtreme, LLC
MARCS-CMS 613230 —
July 09, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2101496
Product:
Tobacco
Recipient:
Vaping Xtreme, LLC
13803 Independence Blvd.
Suite I
Indian Trail
,
NC
28079
United States
mark@vapingxtreme.com
Issuing Office:
Center for Tobacco Products
United States
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 March 1, 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 violations contained in the Warning Letter regarding the website https://vapingxtreme.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 UPS and Electronic Mail
cc:
Ferguson, Hayes, Hawkins & DeMay, PLLC
Attn: Brian Hayes
45 Church St. S
Concord, NC 28026
hayes@concordlawyers.com
GoDaddy.com, LLC
abuse@godaddy.com
Google, LLC
google-cloud-compliance@google.com
Content current as of:
07/30/2021
Regulated Product(s)
Tobacco