tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
BloVape
MARCS-CMS 612957 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101476
Product:
Tobacco
Recipient:
Recipient Name
Corey J. Stanbery
BloVape
United States
blovape@yahoo.com
Issuing Office:
Center for Tobacco Products
United States
Dear Corey J. Stanbery:
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 22, 2021, March 1, 2021, and March 12, 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://blovape.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
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
blovape.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
06/03/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Blue Eyed Vapor
MARCS-CMS 614786 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101596
Product:
Tobacco
Recipient:
Recipient Name
Laurie Ashburn
Blue Eyed Vapor
United States
(b)(6)
blueeyedvapor@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Laurie Ashburn:
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 May 14, 2021 to our Warning Letter dated May 14, 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://blueeyedvapor.square.site.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
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:
MarkMonitor, Inc (TLDs)
ccops@markmonitor.com
Weebly, Inc.
Weebly-abuse@squareup.com
Content current as of:
06/03/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Bulldog Vapor LLC dba Bullys Vapor LLC
MARCS-CMS 627390 —
June 10, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2201746
Product:
Tobacco
Recipient:
Recipient Name
Supriya Karki and Upendra Dhakal
Bulldog Vapor LLC dba Bullys Vapor LLC
United States
bullysvapor@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Supriya Karki and Upendra Dhakal:
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 18, 2022 and March 7, 2022 to our Warning Letter dated February 18, 2022. 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.bullysvapor.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
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, LLC
abuse@godaddy.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
06/27/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
CAJ Food Products Inc.
MARCS-CMS 624051 —
August 04, 2022
Delivery Method:
VIA EMAIL WITH READ RECEIPT
Product:
Dietary Supplements
Recipient:
Recipient Name
Matt Herzog
Recipient Title
President
CAJ Food Products Inc.
11650 Olio Rd.
Suite 1000
Fishers
,
IN
46037
United States
info@drinkbeetjuice.com
Issuing Office:
Office of Human and Animal Food Operations East Division 6
United States
Dear Mr. Herzog:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter 624051 dated March 11, 2022. 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/
LCDR Kelli L. Wilkinson, RS, CP-FS
Director of Compliance
Human and Animal Food Operations East 6
Content current as of:
08/08/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
The Camel Milk Co. LLC dba Camel Culture
MARCS-CMS 611518 —
December 07, 2022
Delivery Method:
UPS Overnight
Product:
Dietary Supplements
Recipient:
Recipient Name
Ryan Fee
Recipient Title
Owner
The Camel Milk Co. LLC dba Camel Culture
17032 Campo Drive
Parker
,
CO
80134
United States
Issuing Office:
Office of Human and Animal Foods Operations – Division West 4
United States
Dear Mr. Fee:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # CMS 611518, dated September 22, 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/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
Content current as of:
12/20/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Catsmo, LLC
MARCS-CMS 599871 —
April 19, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Markus Draxler
Recipient Title
CEO
Catsmo, LLC
25 Myers Road
Wallkill
,
NY
12589-3516
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 1
United States
Dear Mr. Draxler:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 599871, issued on March 25, 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:
04/25/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Cedar's Mediterranean Foods, Inc.
MARCS-CMS 623473 —
August 04, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Charles L. Hanna
Recipient Title
President and CEO
Cedar's Mediterranean Foods, Inc.
50 Foundation Ave
Ward Hill
,
MA
01835-6926
United States
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
Dear Mr. Hanna:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 623473, issued to your firm on February 11, 2022. 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/
Latoya Griffith
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
08/08/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
CellEra LLC
MARCS-CMS 618209 —
July 21, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Richard E. Moon
Recipient Title
Chief Financial Officer
CellEra LLC
1045 Reed Dr, Ste C
Monroe
,
OH
45050
United States
Issuing Office:
Office of Medical Device and Radiological Health Division 1 – East
United States
Dear Mr. Moon:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, CMS# 618209, dated October 20, 2021 for your firm’s Monroe, OH location. 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 M. Brackett
Director, Compliance Branch
Office of Medical Devices & Radiological Health
Division One - East
Content current as of:
07/25/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Cerreta Candy Company, Inc.
MARCS-CMS 593983 —
November 16, 2022
Delivery Method:
UPS Overnight
Reference #:
DEN-20-03-WL
Product:
Food & Beverages
Recipient:
Recipient Name
Jonathan D. Cerreta
Recipient Title
Vice President
Cerreta Candy Company, Inc.
5345 W. Glendale Ave
Glendale
,
AZ
85301
United States
Issuing Office:
Office of Human and Animal Foods – Division IV West
United States
Dear Mr. Cerreta:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #DEN-20-03-WL, dated January 21, 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/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
Content current as of:
11/23/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Chicago Indoor Garden
MARCS-CMS 606992 —
December 29, 2022
Delivery Method:
VIA EMAIL WITH READ RECEIPT
Product:
Food & Beverages
Recipient:
Recipient Name
Brian Gorman
Recipient Title
President/Owner
Chicago Indoor Garden
4459 Division St.
Chicago
,
IL
60651
United States
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Dear Mr. Gorman:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letters FY2020-HAFE-WL-04 and CHI-4-16. Based on our evaluation, it appears that you have addressed the violation(s) contained in these Warning Letters. 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/
Kelli Wilkinson LCDR
Director of Compliance
Office of Human and Animal Food
Operations Division East 6
Content current as of:
01/03/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
CooperSurgical, Inc.
MARCS-CMS 613339 —
January 19, 2022
Product:
Drugs
Recipient:
Recipient Name
Kim Shaffer
Recipient Title
Assistant General Counsel
CooperSurgical, Inc.
75 Corporate Drive
Trumbull
,
CT
06611
United States
Issuing Office:
The Office of Prescription Drug Promotion (OPDP)
United States
Dear Ms. Shaffer:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated February 12, 2021. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA surveillance 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 subsequent surveillance or through other means.
If you have any questions or comments, please direct your response to the undersigned at the
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266
. A courtesy copy can be sent by facsimile to (301) 847-8444. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA 628 in addition to the NDA number in all future correspondence relating to this particular matter.
Sincerely,
{See appended electronic signature page}
Elvy Varghese, PharmD.
Regulatory Review Officer
Division of Advertising & Promotion Review 2
Office of Prescription Drug Promotion
--------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
--------------------------------------------------------------------------------------------
Content current as of:
06/22/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Cosmic Fog Vapors Operating Company LLC
MARCS-CMS 623562 —
June 10, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101707
Product:
Tobacco
Recipient:
Recipient Name
Robert Crossley, Emily Fraser, and Peter Koch
Cosmic Fog Vapors Operating Company LLC
United States
peterk@cosmicfogvapors.com
emily@cosmicfogvapors.com
rob@cosmicfogvapors.com
Issuing Office:
Center for Tobacco Products
United States
Dear Robert Crossley, Emily Fraser, and Peter Koch:
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 December 21, 2021 to our Warning Letter dated December 20, 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.cosmicgfogvapors.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
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
COSMICFOGVAPORS.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
06/22/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Crystal Canyon Vapes LLC
MARCS-CMS 632020 —
September 12, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2201765
Product:
Tobacco
Recipient:
Recipient Name
Marc Foumberg
Crystal Canyon Vapes LLC
United States
service@ccvapes.com
Issuing Office:
Center for Tobacco Products
United States
Dear Marc Foumberg:
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 May 9, 2022, June 14, 2022, and July 12, 2022, in response to our Warning Letter dated April 22, 2022. 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.ccvapes.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
1&1 Internet Inc.
dataprivacyprotected@ionos.de
IONOS SE
abuse@ionos.com
Content current as of:
09/28/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts
MARCS-CMS 559540 —
January 20, 2022
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Jan R. Gerber
Recipient Title
Owner/President and CEO
Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts
3510 N Ridge Rd.
Suite 900
Wichita
,
KS
67205-1224
United States
Issuing Office:
Detroit District Office
United States
Dear Mr. Gerber:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (Case #559540), dated October 18, 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/
Nicholas F. Lyons
Director of Compliance Branch
Division of Pharmaceutical Quality Operations III
Content current as of:
02/02/2022
Regulated Product(s)
Drugs