tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Riverstone LLC
MARCS-CMS 608645 —
March 18, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Chris LaVoie
Riverstone LLC
51668 Blue River Drive
Blue River
,
OR
97413
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. LaVoie:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 608645, issued December 21, 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/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
03/22/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
RNJ Field Inc d/b/a Thunderhead Corporation Fife
MARCS-CMS 613964 —
July 01, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101552
Product:
Tobacco
Recipient:
Recipient Name
Jinhyung Lee and Ray Lee
RNJ Field Inc d/b/a Thunderhead Corporation Fife
United States
staff@thunderheadvapor.com
1619256066381_645266682@zohomail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Jinhyung Lee and Ray Lee:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your e-mail received by FDA on April 26, 2021, in response to our Warning Letter dated March 26, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.thunderheadvapor.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Sincerely,
/S/
Mallory Johnson
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Domains by Proxy, LLC
thunderheadvapor.com@domainsbyproxy.com
GoDaddy, LLC
abuse@godaddy.com
Google LLC
google-cloud-complance@google.com
Content current as of:
07/07/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Rocky Top Vapor, LLC
MARCS-CMS 614206 —
July 09, 2021
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Dave Nelson
Rocky Top Vapor, LLC
105 Kwick Way Ln
Johnson City
,
TN
37615
United States
rockytopvapor@gmail.com
orders@rockytopvapor.com
wholesale@rockytopvapor.com
Issuing Office:
Center for Tobacco Products
United States
Dear Dave Nelson:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your response dated April 27, 2021 in response to our Warning Letter dated April 9, 2021. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter regarding the website https://www.rockytopvapor.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:
Keller and Heckman LLP
Attn: Azim Chowdhury
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
chowdhury@khlaw.com
GoDaddy.com, LLC
abuse@godaddy.com
Cloudflare, Inc
abuse@cloudflare.com
Content current as of:
07/20/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
RPK Pharmaceuticals Inc.
MARCS-CMS 613400 —
June 01, 2021
Reference #:
#1663
Product:
Drugs
Recipient:
Recipient Name
Rich Mangini
RPK Pharmaceuticals Inc.
3281 Whipple Rd.
Union City
,
CA
94587
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Mr. Rich Mangini,
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 1663. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and corrected the data deficiencies. Future FDA 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 to 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 E. Becker, J.D.
Director, Office of Unapproved Drugs & Labeling Compliance
Center for Drug Evaluation and Research
Office of Compliance
U.S. Food and Drug Administration
Tel:
301-796-8801
carolyn.becker@fda.hhs.gov
CC: San Juan District Office
Content current as of:
06/07/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Rushing Waters Fisheries, LLC
MARCS-CMS 535009 —
July 12, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Peter J. Fritsch
Recipient Title
President
Rushing Waters Fisheries, LLC
N301 County Road H
Palmyra
,
WI
53156-9655
United States
Issuing Office:
Minneapolis District Office
United States
Dear Mr. Fritsch:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 535009 dated November 17, 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/
Dianna C. Sonnenburg
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
07/20/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
SafaLab, Inc.
MARCS-CMS 611233 —
March 18, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Dr. Bradford Weeks
SafaLab, Inc.
317 Cascade Avenue
Langley
,
WA
98260
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Dr. Weeks:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 611233, issued February 18, 2021. 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/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
03/23/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Sage Moon Apothecary LLC
MARCS-CMS 611376 —
May 18, 2021
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Jennifer May
Recipient Title
Owner
Sage Moon Apothecary LLC
40 Main Street
Seal Harbor
,
ME
04675
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Dear Ms. May:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 611376, issued on January 14, 2021. 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:
05/24/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Sage Woman Herbs, Ltd. dba Sage Consulting & Apothecary
MARCS-CMS 608906 —
January 28, 2021
Recipient:
Recipient Name
Ms. Valerie Blankenship
Sage Woman Herbs, Ltd. dba Sage Consulting & Apothecary
2727 North Tejon Street
Colorado Springs
,
CO
80907
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Ms. Blankenship:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 608906, issued November 10, 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/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
01/29/2021
CLOSEOUT LETTER
Sassy Cow Creamery, LLC
MARCS-CMS 587954 —
August 20, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
James J. Baerwolf
Recipient Title
Owner
Sassy Cow Creamery, LLC
W4192 Bristol Road
Columbus
,
WI
53925
United States
Issuing Office:
Division of Human and Animal Food Operations West I
United States
(612) 334-4100
Dear Mr. Baerwolf:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated December 4, 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 ensure 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 Food Operations
Content current as of:
08/23/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Session Supply Company
MARCS-CMS 612797 —
June 08, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101470
Product:
Tobacco
Recipient:
Recipient Name
Dutch Knudson
Session Supply Company
United States
dutch@sessionsupply.com
Issuing Office:
Center for Tobacco Products
United States
Dear Dutch Knudson:
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 January 27, 2021 and February 8, 2021, in response to our Warning Letter dated January 15, 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.sessionsupply.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
GoDaddy.com, LLC
abuse@godaddy.com
Google LLC
Google-cloud_compliance@google.com
Content current as of:
06/22/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Shang Jiuan Co., LTD
MARCS-CMS 588770 —
June 22, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Yu-Ting Su
Recipient Title
General Affairs
Shang Jiuan Co., LTD
No. 1 Dail Road, Sec. 2
Donggang Township
,
Pingtung County
92849
Taiwan
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Ms. Yu-Ting Su:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #588770 issued August 15, 2019. 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/
Robyn R. Jones, Team Leader
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/21/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Shenzhen Weifa Technology Co., Ltd
MARCS-CMS 609828 —
September 27, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Huaquan Yu
Shenzhen Weifa Technology Co., Ltd
Room 403, Building 117, Sungang Village, Baogang Road
Sungang Street
Shenzhen Shi
Guangdong Sheng
,
518100
China
info@starkit.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Huaquan Yu:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 609828, March 11, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely yours,
/S/
Donna Engleman, MS, BSN
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
09/27/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Shung Kee Food Co., Ltd.
MARCS-CMS 598630 —
December 07, 2021
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Yuk Leung Lok
Recipient Title
President
Shung Kee Food Co., Ltd.
162 42nd St
Brooklyn
,
NY
11232-3317
United States
shungkeefood@gmail.com
Issuing Office:
Office of Human and Animal Food Operations East Division 1
United States
Dear Mr. Lok:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 598630, issued on March 20, 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/
Scott M. Loughan
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
12/14/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Silver Star Brands, Inc.
MARCS-CMS 612268 —
September 27, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Bruce Valk
Recipient Title
President
Silver Star Brands, Inc.
250 City Center
Oshkosh
,
WI
54906
United States
MKosanke@silverstarbrands.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Secondary Issuing Offices
United States
Dear Mr. Valk,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 612268, issued February 18, 2021. Based on our evaluation, it appears you have addressed the products associated with 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/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
08/04/2025
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Smokin Fire Vapor
MARCS-CMS 614413 —
July 09, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101582
Product:
Tobacco
Recipient:
Recipient Name
Chris Weddington
Smokin Fire Vapor
United States
smokinfirevapor@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Chris Weddington:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your responses dated April 23, 2021, April 24, 2021, and May 10, 2021 in response to our Warning Letter dated April 23, 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://smokinfirevapor.com.
However, our surveillance shows you continue to offer for sale to customers in the United States other tobacco products that may be subject to market authorization requirements. FDA encourages you to discuss with your suppliers the current status of any particular tobacco product’s marketing application or any product’s marketing authorization. For additional information regarding currently marketed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement, please visit our website
https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-lists?utm_medium=email&utm_source=govdelivery#list%20of%20deemed
.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Sincerely,
/S/
Nathan Everly
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
GoDaddy.com, LLC
abuse@godaddy.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
07/20/2021
Regulated Product(s)
Tobacco