tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Davati Medical Supply LLC
MARCS-CMS 615530 —
October 14, 2021
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Biologics
Recipient:
Recipient Name
Philip Quick
Recipient Title
Vice President of Operations
Davati Medical Supply LLC
3121 Eagles Nest St.
Suite 120
Round Rock
,
TX
78665
United States
pquick@davatimedical.com
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Dear Mr. Quick:
The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to the Warning Letter (#CBER 21-02) issued by FDA to Davati Medical Supply, LLC on June 26, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this WL. 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.
If you have any questions regarding this letter, please contact the Division of Case Management, CBER at (240) 402-9155 or CBERDCMRecommendations@fda.hhs.gov. Please be advised that only written communications are considered official.
Sincerely,
/S/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Content current as of:
10/14/2021
Regulated Product(s)
Biologics
CLOSEOUT LETTER
DC Vapor, Inc.
MARCS-CMS 613223 —
July 09, 2021
Delivery Method:
VIA Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Barry Vuong
DC Vapor, Inc.
United States
barry@dcvapor.com
vapeordersDMV@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Barry Vuong:
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 emails dated March 7, 2021 and April 9, 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://www.dcvapor.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-tobaccoproduct/deemed-new-tobacco-product-applicationslistsutm_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
DCVapor.com@domainsbyproxy.com
paragonvapelabs.com@domainsbyproxy.com
Paragon Vape Labs
paragonvapelabs@gmail.com
customerservice@paragonvapelabs.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
07/26/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
DCA Inc. dba Beacon Prescriptions
MARCS-CMS 525833 —
September 22, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
3005823862
Product:
Drugs
Recipient:
Recipient Name
Annik S. Chamberlin
Recipient Title
PharmD
DCA Inc. dba Beacon Prescriptions
690 North Main Street
Southington
,
CT
06489-2529
United States
Issuing Office:
OPQO Division I / New Jersey District
United States
(973) 331-4900
Dear Dr. Chamberlin:
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 #525833], dated June 1, 2017. 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.
If you have any questions, contact Compliance Officer Juan Jimenez at
orapharm1_responses@fda.hhs.gov
; and
juan.jimenez@fda.hhs.gov
. Please identify correspondence with FEI # 3005823862.
Sincerely,
Diana Amador-Toro
Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District
Diana Amadortoro
-S
Digitally signed by Diana Amador-toro -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1
Content current as of:
09/28/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Diamond Rock Food Imports Inc.
MARCS-CMS 607128 —
November 22, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Wesley E. Alvarado
Recipient Title
CEO
Diamond Rock Food Imports Inc.
1199 Sunrise Hwy Ste 2-3
Copiague
,
NY
11726
United States
Issuing Office:
Division of Northeast Imports
United States
Dear Mr. Wesley E. Alvarado:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 607128 dated June 8, 2020. Based on our evaluation, it appears that you have addressed the violation 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/
Anna Alexander
Compliance Director
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration
Content current as of:
12/13/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Distribuidora La Jugosita, Inc.
MARCS-CMS 532714 —
April 30, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
17-OHAFOE4-WL-07
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. William Rodriquez
Recipient Title
President
Distribuidora La Jugosita, Inc.
Carretera #1, Km. 50.9
Cidra
,
PR
00739
United States
info@lajugosita.com
Issuing Office:
San Juan District Office
United States
(787) 729-8500
Dear Mr. Rodriguez:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 17-OHAFOE4-WL-07 dated August 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.
Kind regards,
/S/
Marilyn Santiago
Acting Director, Compliance Branch
Office of Human and Animal Food Operations
Division IV East
Content current as of:
05/10/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Dongguan City Xinyuan Nonwoven Co., Ltd.
MARCS-CMS 612354 —
September 27, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Jack Cheng
Dongguan City Xinyuan Nonwoven Co., Ltd.
Dajin 1st Road
Dajin Industrial Park, Xixi
Liaobu Town
Dongguan Shi
Guangdong Sheng
,
523402
China
sales01@xinyuanmask.com
992248477@qq.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Cheng:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 612354, May 27, 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:
10/04/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Dr Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid
MARCS-CMS 612790 —
June 04, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101468
Product:
Tobacco
Recipient:
Recipient Name
Michael Noe
Dr Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid
United States
DrCrimmys@Drcrimmy.com
Issuing Office:
Center for Tobacco Products
United States
Dear Michael Noe:
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 18, 2021, January 28, 2021, February 5, 2021, February 23, 2021, and April 29, 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.drcrimmy.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 Electronic Mail
cc:
Keller and Heckman LLP
Attn: Azim Chowdhury
chowdhury@khlaw.com
Domains by Proxy, LLC
DRCRIMMY.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Cloudflare, Inc.
abuse@cloudfare.com
Content current as of:
06/16/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Dr. Garber’s Natural Solutions
MARCS-CMS 612226 —
June 25, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Dr. Stuart H. Garber, D.C., Ph.D., AVCA
Dr. Garber’s Natural Solutions
2607 2nd St #1
Santa Monica
,
CA
90405
United States
office@drgarbers.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Dr. Garber,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 612226, 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
Dual Health Body and Mind
MARCS-CMS 545453 —
April 12, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Angie Walter
Dual Health Body and Mind
188 5th Creek Road
Statesville
,
NC
28625
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Ms. Walter:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 545453, issued May 29, 2018. 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:
04/14/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
E Cigarette Empire LLC
MARCS-CMS 608450 —
August 02, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001359
Product:
Tobacco
Recipient:
Recipient Name
Jim Petty
E Cigarette Empire LLC
11226 North 23rd Avenue
Suite 103
Phoenix
,
AZ
85029
United States
support@vapejuice.com
Issuing Office:
Center for Tobacco Products
United States
Dear Jim Petty:
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 August 6, 2020, August 28, 2020, July 2, 2021, and July 26, 2021, 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.ecigaretteempire.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:
Keller and Heckman LLP
Attn: Azim Chowdhury
chowdhury@khlaw.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
08/13/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
ECig Warehouse, Inc.
MARCS-CMS 605736 —
June 25, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001275
Product:
Tobacco
Recipient:
Recipient Name
Robert Testagrossa
ECig Warehouse, Inc.
319 Lafayette St
Box 176
New York
,
NY
10012
United States
admin@cloud99vapes.com
info@cloud99vapes.com
Issuing Office:
Center for Tobacco Products
United States
Dear Robert Testagrossa:
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 27, 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.cloud99vapes.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:
ECig Warehouse, Inc.
21 Doxbury Lane
Suffern, NY 10901
GoDaddy.com, LLC
abuse@godaddy.com
Google, LLC
google-cloud-compliance@google.com
Content current as of:
07/02/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
El Molino Bakery Supplies Inc
MARCS-CMS 593693 —
June 22, 2021
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Diana Ortegon
Recipient Title
General Manager
El Molino Bakery Supplies Inc
2875 N Berkley Lake Rd NW Ste 19
Duluth
,
GA
30096-4344
United States
Issuing Office:
Division of Southeast Imports
United States
Dear Ms. Diana Ortegon:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter #593693, issued December 16, 2019. 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/
Tammara P. Threats
Director, Compliance Branch
Division of Southeast Imports
Content current as of:
06/28/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Electronic Puff
MARCS-CMS 535063 —
August 02, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW1700766
Product:
Tobacco
Recipient:
Electronic Puff
United States
admin@electronicpuff.co.uk
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 following the issuance of our Warning Letter dated August 17, 2017. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter regarding your website http://www.electronicpuff.co.uk.
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:
EU Linode/Linode LLC
abuse@linode.com
Content current as of:
08/06/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Entia Biosciences, Inc.
MARCS-CMS 610493 —
April 29, 2021
Delivery Method:
Overnight Delivery
Product:
Dietary Supplements
Recipient:
Recipient Name
Timothy A. Timmins
Recipient Title
President
Entia Biosciences, Inc.
8245 SW 166th Place
Beaverton
,
OR
97007
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
Dear Mr. Timmins:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS 610493, dated January 6, 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/
Miriam R. Burbach
District Director
Program Division Director
Content current as of:
05/12/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Enzymology Research Center, Inc.
MARCS-CMS 604613 —
March 01, 2021
Product:
Drugs
Recipient:
Recipient Name
Troy A. Aupperle
Recipient Title
Owner
Enzymology Research Center, Inc.
332 West Street N.
Miltona
,
MN
56354-8256
United States
Issuing Office:
Office of Human and Animal Foods - West Division 1
United States
Dear Mr. Aupperle:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated March 26, 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/
Boun M. Xiong
Compliance Officer, West Division 1 – CB
Office of Human and Animal Food Operations
Content current as of:
03/08/2021
Regulated Product(s)
Drugs