tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Bulldog Vapor LLC
MARCS-CMS 613471 —
June 04, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101507
Product:
Tobacco
Recipient:
Recipient Name
Wesley Swanson
Bulldog Vapor LLC
United States
Issuing Office:
Center for Tobacco Products
United States
Dear Wesley Swanson:
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 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://bulldog-vapor.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:
GoDaddy.com, LLC
abuse@godaddy.com
Google, LLC
google-cloud-compliance@google.com
Content current as of:
06/16/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
California IVF Fertility Center
MARCS-CMS 598552 —
August 09, 2021
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Reference #:
OBPO 20-598522
Product:
Biologics
Recipient:
Recipient Name
Ernest Zeringue, MD
California IVF Fertility Center
2590 Venture Oaks Way
Suite 102 & 103
Sacramento
,
CA
95833-3200
United States
Issuing Office:
Office of Biological Products Operations - Division II
United States
Dear Dr. Zeringue,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, WL #OBPO 20-598522 issued February 26, 2020. 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/
Samuel Labinjo Compliance Officer
U.S. Food and Drug Administration
Office of Biological Products Operations Division II
Compliance Branch
Samuel.Labinjo@fda.hhs.gov
Content current as of:
08/13/2021
Regulated Product(s)
Biologics
CLOSEOUT LETTER
California Vaping Company Inc.
MARCS-CMS 613513 —
June 04, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101513
Product:
Tobacco
Recipient:
Recipient Name
Dakoda Collins
California Vaping Company Inc.
United States
Sales@CaliVapeCo.com
Issuing Office:
Center for Tobacco Products
United States
Dear Dakoda Collins:
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 10, 2021, March 16, 2021, and May 19, 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://calivapeco.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:
GoDaddy.com, LLC
abuse@godaddy.com
Liquid Web, L.L.C
abuse@liquidweb.com
Content current as of:
06/08/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Campolor, Inc.
MARCS-CMS 575789 —
August 18, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
21-HAFE4-WLCOL - 07
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Melvin Arroyo
Recipient Title
President/Owner
Campolor, Inc.
El Tuque Industrial Park, Bo. La Cuarta,
Calle A, Edificio 2
Ponce
00715
Puerto Rico
m.arroyo@campolor.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
(787) 729-8500
Dear Mr. Arroyo:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter No. 19-HAFE4-WL-06 dated March 8, 2019. 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/
Ramon Hernandez,
Program Division Director
OHAFO, Division IV East
Content current as of:
08/23/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Captain’s Cloth
MARCS-CMS 613965 —
September 27, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Brian Eckert
Captain’s Cloth
28871 El Apajo
Laguna Niguel
,
CA
92677
United States
brian@captainscloth.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Eckert:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613965, July 2, 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:
10/07/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Castle Rock Vapor LLC
MARCS-CMS 612780 —
June 04, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2001461
Product:
Tobacco
Recipient:
Recipient Name
William Connolly
Castle Rock Vapor LLC
United States
Issuing Office:
Center for Tobacco Products
United States
Dear William Connolly:
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 15, 2021, January 18, 2021, and February 5, 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://shop.castlerockvapor.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:
Domains By Proxy, LLC
CASTLEROCKVAPOR.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
06/08/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Chief Vapor
MARCS-CMS 612973 —
July 01, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101478
Product:
Tobacco
Recipient:
Recipient Name
Tanner Adams
Chief Vapor
United States
Issuing Office:
Center for Tobacco Products
United States
Dear Tanner Adams:
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, March 8, 2021, April 1, 2021, and June 23, 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://chiefvapor.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,
David Rice
/S/
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
chiefvapor.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Google LLC
Google-cloud-compliance@google.com
Content current as of:
07/19/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Chuckin' Clouds Vape Shop Inc
MARCS-CMS 613515 —
June 04, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101514
Product:
Tobacco
Recipient:
Recipient Name
Zackwrie Parr
Chuckin' Clouds Vape Shop Inc
United States
chuckincloudslab@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Zackwrie Parr:
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 3, 2021, March 24, 2021, and April 1, 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://chuckinclouds.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:
Tucows Domains Inc.
domainabuse@tucows.com
Google LLC
Google-cloud_compliance@google.com
Content current as of:
06/22/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
The Clean Vape
MARCS-CMS 613733 —
July 01, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101519
Product:
Tobacco
Recipient:
Recipient Name
Raffi Tasmajian
The Clean Vape
United States
support@thecleanvape.com
raffi.tasmajian@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Raffi Tasmajian:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in Warning Letter Responses emailed and dated March 12, 2021, April 2, 2021, April 20, 2021 and April 21, 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.thecleanvape.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:
WhoisGuard, Inc.
9607c558a4e640e998f05214216eee8c.protect@whoisguard.com
NameCheap, Inc.
abuse@namecheap.com
DigitalOcean, LLC
abuse@digitalocean.com
Content current as of:
07/21/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Clinicon Corp
MARCS-CMS 582801 —
April 30, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Fritz A. Brauer
Recipient Title
President / CEO
Clinicon Corp
3025 Industry St.
Ste. A
Oceanside
,
CA
92054
United States
ccfab7@clinicon.com
Issuing Office:
Division of Medical Device and Radiological Health Operations West
United States
Dear Mr. Brauer:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #582801 dated June 20, 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 Mu
Director of Compliance Branch
Office of Medical Device and Radiological Health
Division 3/West
Content current as of:
05/11/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Cloud Chasers Apothecary LLC
MARCS-CMS 612963 —
June 04, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101473
Product:
Tobacco
Recipient:
Recipient Name
Curtis Glardon
Cloud Chasers Apothecary LLC
United States
sales@ccapothecary.com
Issuing Office:
Center for Tobacco Products
United States
Dear Curtis Glardon:
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 11, 2021 and March 10, 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://ccapothecary.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:
Register.com, Inc.
abuse@web.com
Google LLC
google-cloud-compliance@google.com
c/o Weebly Domains
questions@weebly.com
Content current as of:
06/16/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Cloudchasor LLC
MARCS-CMS 613129 —
June 04, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101533
Product:
Tobacco
Recipient:
Recipient Name
James Kaufmann
Cloudchasor LLC
United States
Issuing Office:
Center for Tobacco Products
United States
Dear James Kaufmann:
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 30, 2021, 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 Letter regarding your website https://cloudchasor.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:
GoDaddy.com, LLC
abuse@godaddy.com
WEBSITEWELCOME.COM
abuse@hostgator.com
Content current as of:
06/16/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
CLS Trading, LLC dba Vape Dudes HQ
MARCS-CMS 612798 —
July 06, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101471
Product:
Tobacco
Recipient:
Recipient Name
Chris Snuffer
CLS Trading, LLC dba Vape Dudes HQ
United States
chris@vapedudes.com
Issuing Office:
Center for Tobacco Products
United States
Dear Chris Snuffer:
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 2, 2021 and June 9, 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.vapedudes.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:
Tucows, Inc.
domainabuse@tucows.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
07/19/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Conformis Inc.
MARCS-CMS 596362 —
July 28, 2021
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Mark A. Augusti
Recipient Title
President, CEO
Conformis Inc.
600 Technology Park Dr.
Billerica
,
MA
01821
United States
Issuing Office:
Office of Medical Device and Radiological Health Operations
United States
Dear Mr. Augusti:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 596362) issued on December 12, 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/
Gina Brackett
Director, Compliance Branch
Office of Medical Device and Radiological Health Division 1
Content current as of:
07/30/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Daily Manufacturing Company
MARCS-CMS 609000 —
January 28, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. James W. Daily, III
Daily Manufacturing Company
4820 Pless Road
Rockwell
,
NC
28138
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Daily:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 609000, issued October 9, 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:
02/02/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Databazaar.com
MARCS-CMS 617199 —
September 27, 2021
Product:
Medical Devices
Recipient:
Databazaar.com
16777 SW 36th Street
Miramar
,
FL
33027
United States
support@databazaar.com
Issuing Office:
Center for Devices and Radiological Health
United States
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 617199, September 3, 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:
11/01/2021
Regulated Product(s)
Medical Devices