tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Apple Tree Goat Dairy
MARCS-CMS 509219 —
September 30, 2021
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Linda H. Nussbaum
Recipient Title
Co-Owner
Apple Tree Goat Dairy
129 North Nenix Hill Rd
Richfield
,
PA
17086-8555
United States
appletreegoatdairy@emypeople.net
Issuing Office:
Human & Animal Food Division East II
United States
Dear Linda Nussbaum,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 17-PHI-04, dated February 10, 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 phone: 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)
Kyle Hobson, State Liaison (Kyle.Hobson@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 E. DiGennaro, Supervisory Consumer Safety Officer (Margaret.DiGennaro@fda.hhs.gov)
Content current as of:
10/08/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Artist Liquid Laboratories LLC
MARCS-CMS 583546 —
April 27, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW1901099
Product:
Tobacco
Recipient:
Recipient Name
Travis Bain and Robert Branting
Artist Liquid Laboratories LLC
United States
travis@artistliquidlabs.com
Issuing Office:
Center for Tobacco Products
United States
Dear Travis Bain and Robert Branting:
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 June 7, 2019 and April 15, 2021 in response to our Warning Letter dated June 7, 2019. Based on our evaluation, we note that your firm is no longer in operation and your websites identified in the Warning Letter have been inactivated.
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
Content current as of:
04/30/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
AusarHerbs
MARCS-CMS 610976 —
March 18, 2021
Product:
Dietary Supplements
Recipient:
AusarHerbs
201 South D Street
Madera
,
CA
93639
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
To Whom It May Concern:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 610976, issued January 12, 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
Austin Vapor
MARCS-CMS 612956 —
June 02, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101474
Product:
Tobacco
Recipient:
Recipient Name
Michael Laughlin and Justin Laughlin
Austin Vapor
United States
michaeldlaughlin@gmail.com
jklaughlin@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Michael Laughlin and Justin Laughlin:
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 February 12, 2021, February 26, 2021, and March 26, 2021 in response to our Warning Letter dated January 29, 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.austinvapor.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 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:
Cloudflare, Inc.
abuse@cloudflare.com
Contact Privacy Inc. Customer 1241107912
xxp6abeazo4i@contactprivacy.email
Google LLC
registrar-abuse@google.com
Content current as of:
06/07/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
AZ Swagg Sauce LLC
MARCS-CMS 607686 —
June 25, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001351
Product:
Tobacco
Recipient:
Recipient Name
Bashar Dababneh
AZ Swagg Sauce LLC
13646 North 19th Ave
Phoenix
,
AZ
85029
United States
swaggsauceusa@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Bashar Dababneh:
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 June 10, 2021, in response to our Warning Letter dated May 28, 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://swaggsauce.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:
AZ Swagg Sauce LLC
Attn: Bashar Dababneh
1907 W. Thunderbird Rd
Phoenix, AZ 85032
Troutman Sanders LLP
Attn: Bryan M. Haynes
Bryan.haynes@troutman.com
Domains by Proxy, LLC
SWAGGSAUCE.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify Operations
abuse@shopify.com
Content current as of:
07/19/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
B4B Corp.
MARCS-CMS 609521 —
March 18, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Busta Sinclair
B4B Corp.
40 Remsen Avenue
Brooklyn
,
NY
11212
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Sinclair:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 609521, 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:
03/22/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Baker’s Best Health Products, Inc.
MARCS-CMS 544600 —
March 16, 2021
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Jeffery Baker
Recipient Title
President
Baker’s Best Health Products, Inc.
46925 West Road
Wixom
,
MI
48393
United States
Issuing Office:
Chicago District Office
United States
Dear Mr. Baker:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY18-HAFE6-06. 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/
LCDR Kelli L. Wilkinson, Director
Compliance Branch
Human and Animal Food Operations
Division East 6
Content current as of:
05/11/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Battelle Memorial Institute
MARCS-CMS 610928 —
October 27, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Jeff Rose
Recipient Title
Vice President Government Relations and Public Policy
Battelle Memorial Institute
505 King Ave.
Columbus
,
OH
43201
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Rose:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 610928, dated October 7, 2020). Based on our review of your responses, you have addressed the violations contained in this Warning Letter.
The establishment inspections are considered closed as you have ceased operations and your Emergency Use Authorization (EUA) for the Battelle CCDS’ has been revoked. In the event that Battelle re-enters this product area either through a new EUA or marketing application, the issues identified during the inspections would need to be corrected. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
Following revocation of your EUA, you should continue to report adverse events and maintain all records in accordance with the NIOSH – approved FFR EUA (https://www.fda.gov/media/135763/download). During our call on March 30, 2021, we mentioned maintaining records for 2 years which is considered best practice; however, we would like to note that the linked EUA under which the decontaminated respirators would remain authorized, states that all records should be maintained until otherwise notified by FDA.
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/
Binita S. Ashar, MD, MBA, F.A.C.S.
Director
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
11/29/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Beauty Manufacturing Solutions Corp.
MARCS-CMS 535116 —
May 27, 2021
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Mr. Whoojong (Peter) I. Song
Recipient Title
CEO
Beauty Manufacturing Solutions Corp.
1250 Freeport Pkwy
Coppell
,
TX
75019
United States
psong@beautymanufacture.com
Issuing Office:
Dallas District Office
United States
Dear Mr. Song:
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 No. 535116) dated January 12, 2018 and our meeting with you on December 12, 2018. 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/
John W. Diehl, M.S.
Commander, U.S. Public Health Service
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
06/02/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Bershtel Enterprises LLC dba WePackItAll
MARCS-CMS 570885 —
July 21, 2021
Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs
Recipient:
Recipient Name
Natan Bershtel
Recipient Title
President
Bershtel Enterprises LLC dba WePackItAll
2745 Huntington Dr.
Duarte
,
CA
91010
United States
Issuing Office:
United States
Dear Mr. Bershtel:
The U.S. Food and Drug Administration has completed an evaluation of your response to our Warning Letter (Ref CMS 570885) dated May 2, 2019. Based on our evaluation, it appears that you have adequately 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 Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
07/30/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Black Dog Reserve LLC
MARCS-CMS 613510 —
July 26, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101511
Product:
Tobacco
Recipient:
Recipient Name
Corey Tunnell
Black Dog Reserve LLC
United States
blackdogreserve@gmail.com
vapeadvantage1@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Corey Tunnell:
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 26, 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://blackdogreserve.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
Content current as of:
07/30/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Blossom Nature, LLC
MARCS-CMS 612263 —
June 25, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Natalie Krassowizki
Recipient Title
Owner
Blossom Nature, LLC
1193 Elederberry Circle
Folsom
,
CA
95630
United States
katherine@sglawfl.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Ms. Krassowizki,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 612263, 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 Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/21/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Blue Lab Vapors, LLC
MARCS-CMS 613746 —
July 06, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2101536
Product:
Tobacco
Recipient:
Recipient Name
Fred Jeffery
Blue Lab Vapors, LLC
3970 Tampa Road Ste C
Oldsmar
,
FL
34677
United States
Issuing Office:
Center for Tobacco Products
United States
Dear Fred Jeffrey:
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 March 12, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Lette regarding your website https://www.bluelabvapors.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:
Jeffery Group, LLC
Attn: Fred Jeffrey and Daniel Jeffery
7010 Potomac Drive
Port Richey, FL 34668
Domains By Proxy, LLC
Bluelabvapors.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
1&1 Ionos Inc.
abuse@1&1.com
Content current as of:
07/19/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Bodyhealth.com, LLC
MARCS-CMS 610728 —
December 17, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
21-HAFE4-WL-01
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. David I. Minkoff
Recipient Title
Owner
Bodyhealth.com, LLC
745 Main St.
Dunedin
,
FL
34698-5018
United States
drminkoff@bodyhealth.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Dear Mr. Minkoff:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to 21-HAFE4-WL-01, dated December 09, 2020. 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, Division IV East
Content current as of:
12/17/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Brilliant Enterprises LLC
MARCS-CMS 609523 —
December 06, 2021
Delivery Method:
Via Email
Reference #:
FY 21- HAFE6 WL- 03
Product:
Food & Beverages
Recipient:
Recipient Name
Adam and Angela Schultz
Brilliant Enterprises LLC
621 Main Street
Unit 182
Gaylord
,
MI
49735
United States
support@levelupmushrooms.com
Issuing Office:
Office of Human and Animal Food Operations Division- East 6
United States
Dear Adam and Angela Schultz,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter FY 21- HAFE6 WL- 03. 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/
Lauren E. Sexton
Compliance Officer
Office of Human and Animal Food Operations
Division East 6
Content current as of:
12/14/2021
Regulated Product(s)
Food & Beverages