tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
VallHund Vapes Inc.
MARCS-CMS 553031 —
July 13, 2018
Recipient:
VallHund Vapes Inc.
United States
Issuing Office:
United States
U.S. Food & Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
VIA Electronic Mail
Michael De Pinto
VallHund Vapes Inc.
vallhundvapes@gmail.com
RE: Warning Letter issued to VallHund Vapes Inc. (RW1800854)
Dear Michael De Pinto:
On May 10, 2018, the United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Chill Purple Grape e-liquid product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because its labeling and/or advertising is false or misleading.
The Warning Letter also informed you that this product is misbranded under section 903(a)(7)(B) because you sold it to a person younger than 18 years of age, in violation of 21 C.F.R. § 1140.14(b)(1).
Specifically, FDA determined that the labeling and/or advertising of your Chill Purple Grape e-liquid is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.
FDA also determined that a person younger than 18 years of age was able to purchase Chill Purple Grape e-liquid from your website.
On May 10, 2018, you sent FDA a response to the Warning Letter, and we had a teleconference on May 11, 2018 to discuss the Warning Letter and your response. In response to the Warning Letter, you stated that you implemented corrective actions to address the violations identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violations identified in the Warning Letter.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C 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.
Should you have any questions or concerns, please contact me at
(301) 796-9235
or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/s/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
Vapefu LLC
MARCS-CMS 562956 —
October 26, 2018
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
1800936
Product:
Tobacco
Recipient:
Recipient Name
Igor Gromadskiy
Vapefu LLC
2417 Ave U
Brooklyn
,
NY
11229
United States
info@vapefu.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Igor Gromadskiy:
On September 12, 2018, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Candy King Sour Worms e-liquid product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because its labeling and/or advertising is false or misleading. Specifically, FDA determined that the labeling and/or advertising of your Candy King Sour Worms e-liquid is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.
On September 12, 2018, September 19, 2018, and September 20, 2018, you sent FDA a response to the Warning Letter. Additionally, a teleconference was held on October 9, 2018. In response to the Warning Letter, you stated you implemented corrective actions to address the violation identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violation identified in the Warning Letter. We note that you may have other tobacco products with labeling and/or advertising that causes the product to be misbranded for similar reasons to those discussed above. You are responsible for taking any necessary actions to bring your tobacco products into compliance with the requirements of the law.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C 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.
Should you have any questions or concerns, please contact me at
(301) 796-9235
or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/S/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
Azim Chowdhury
Keller and Heckman LLP
1001 G Street NW, Suite 500 West
Washington, DC 20001
chowdhury@khlaw.com
Domains By Proxy, LLC
Vapefu.com@domainsbyproxy.com
GoDaddy, LLC
abuse@godaddy.com
Content current as of:
04/11/2019
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
The Vapor Studio LLC
MARCS-CMS 562776 —
October 24, 2018
Delivery Method:
UPS and Electronic Mail
Recipient:
Recipient Name
Earl Wilson, Delia Wilson, and C.J. Wilson
The Vapor Studio LLC
11139 N. IH 35
Suite 176
Austin
,
TX
78753
United States
thevaporstudio@gmail.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Earl Wilson, Delia Wilson, and C.J. Wilson:
On September 12, 2018, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Candy King Batch e-liquid product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because its labeling and/or advertising is false or misleading. Specifically, FDA determined that the labeling and/or advertising of your Candy King Batch e-liquid is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.
On September 27, 2018 and September 28, 2018, you sent FDA a response to the Warning Letter, and we held a teleconference on October 10, 2018 to discuss the Warning Letter and your response. In response to the Warning Letter, you stated that you implemented corrective actions to address the violation identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violation identified in the Warning Letter. We note that you may have other tobacco products with labeling and/or advertising that causes the product to be misbranded for similar reasons to those discussed above. You are responsible for taking any necessary actions to bring your tobacco products into compliance with the requirements of the law.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C 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.
Should you have any questions or concerns, please contact me at
(301) 796-9235
or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/S/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
cc:
Azim Chowdhury
Keller and Heckman LLP
1001 G Street NW, Suite 500 West
Washington, DC 20001
chowdhury@khlaw.com
GoDaddy.com, LLC
abuse@godaddy.com
Bigcommerce, Inc.
abuse@bigcommerce.com
Content current as of:
03/28/2019
CLOSEOUT LETTER
Vapor Unlimited, LLC d/b/a Fogworks
MARCS-CMS 562953 —
November 06, 2018
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
1800941
Product:
Tobacco
Recipient:
Recipient Name
Trevor Campbell
Vapor Unlimited, LLC d/b/a Fogworks
32733 Eiland Blvd.
Ste 102
Wesley Chapel
,
FL
33545
United States
vaporunlimtedllc@gmail.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Trevor Campbell:
On September 12, 2018, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Candy King Sour Worms e-liquid product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because its labeling and/or advertising is false or misleading. Specifically, FDA determined that the labeling and/or advertising of your Candy King Sour Worms e-liquid is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.
On September 13, 2018, September 17, 2018, and September 27, 2018, you sent FDA a response to the Warning Letter, and we held teleconferences on September 13, 2018 and October 16, 2018 to discuss the Warning Letter and your response. In response to the Warning Letter, you stated that you implemented corrective actions to address the violation identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violations identified in the Warning Letter. We note that you may have other tobacco products with labeling and/or advertising that causes the product to be misbranded for similar reasons to those discussed above. You are responsible for taking any necessary actions to bring your tobacco products into compliance with the requirements of the law.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C 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.
Should you have any questions or concerns, please contact me at (301) 796-9235 or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/S/
Ele lbarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
Azim Chowdhury
Keller and Heckman LLP
1001 G Street NW, Suite 500 West
Washington, DC 20001
chowdhury@khlaw.com
Registration Private
Domains By Proxy, LLC
fogworks.org@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Content current as of:
04/11/2019
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Virtue Vape LLC
MARCS-CMS 553204 —
July 13, 2018
Recipient:
Virtue Vape LLC
United States
Issuing Office:
United States
U.S. Food & Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
VIA UPS and Electronic Mail
Catalina Jimenez
Virtue Vape LLC
105 Oak Park Drive, Suite A
Mooresville, NC 28115
catalina@virtuevape.com
RE: Warning Letter issued to Virtue Vape LLC (RW1800863)
Dear Catalina Jimenez:
On May 10, 2018, the United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Unicorn Cakes e-liquid is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because its labeling and/or advertising is false or misleading
.
Specifically, FDA determined that the labeling and/or advertising of your Unicorn Cakes e-liquid is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.
On May 30, 2018, June 28, 2018, and July 11, 2018 you sent FDA a response to the Warning Letter, and we held a teleconference on June 11, 2018 and July 15, 2018 to discuss the Warning Letter and your response. In response to the Warning Letter, you stated that you implemented corrective actions to address the violations identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violation identified in the Warning Letter. We note that you may have other tobacco products with labeling and/or advertising that causes the product to be misbranded for similar reasons to those discussed above. You are responsible for taking any necessary actions to bring your tobacco products into compliance with the requirements of the law.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C 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.
Should you have any questions or concerns, please contact me at
(301) 796-9235
or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/s/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Virtue Vape LLC
Attn: Paul Kettlewell
paul@virtuevape.com
Virtue Vape LLC
Attn: John Abbey
john@virtuevape.com
GoDaddy.com, Inc.
abuse@godaddy.com
Big Commerce
abuse@bigcommerce.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
Walter's Pharmacy, Inc.
MARCS-CMS 506596 —
May 09, 2018
Recipient:
Walter's Pharmacy, Inc.
United States
Issuing Office:
United States
Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd FL
Parsippany, NJ 07054
Telephone:
(973) 331-4900
FAX:
(973) 331-4969
Wednesday, May 9, 2018
Mr. Howard Anthony, Owner
Walter’s Pharmacy, Inc.
401 N 17th St
Allentown, PA 18104-5034
Dear Mr. Anthony:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (17-PHI-03; CMS # 506596) issued on January 11, 2017. We acknowledge that your firm no longer produces sterile drug products. 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 assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. If you decide to resume production of drug products intended to be sterile, FDA strongly recommends that you undertake a comprehensive assessment of your operations, including facility design, and that you notify FDA prior to resuming sterile production. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Diana Amador Toro
Division Director/OPQ Division 1
New Jersey District Office
Content current as of:
05/17/2018
CLOSEOUT LETTER
Warrender Enterprise Inc. d/b/a Lifted Liquids and E-Liquid Retail
MARCS-CMS 553196 —
July 31, 2018
Recipient:
Warrender Enterprise Inc. d/b/a Lifted Liquids and E-Liquid Retail
United States
Issuing Office:
United States
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
July 31, 2018
VIA UPS and Electronic Mail
Nicholas S. Warrender
Warrender Enterprise Inc.
d/b/a Lifted Liquids and E-Liquid Retail
12715 210
th
Avenue
Bristol, WI 53104
info@liftedliquids.com
RE: Warning Letter issued to Warrender Enterprise Inc. d/b/a Lifted Liquids and E-Liquid Retail (RW1800864)
Dear Nicholas S. Warrender:
On May 1, 2018, the United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Vape Heads Sour Smurf Sauce e-liquid product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because its labeling and/or advertising is false or misleading
.
Specifically, FDA determined that the labeling and/or advertising of your Vape Heads Sour Smurf Sauce e-liquid is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.
On May 2, 2018, June 14, 2018, July 12, 2018, and July 19, 2018, you sent FDA a response to the Warning Letter, and we held teleconferences on June 13, 2018 and July 19, 2018 to discuss the Warning Letter and your response. In response to the Warning Letter, you stated that you implemented corrective actions to address the violation identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violation identified in the Warning Letter.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C 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.
Should you have any questions or concerns, please contact me at
(301) 796-9235
or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/S/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
H. Scott Hecker
Law Offices of H. Scott Hecker, P.A.
400 Southeast Ninth Street
Fort Lauderdale, FL 33316
heckerlawfirm@gmail.com
Nicholas Warrender
liftedbusiness@gmail.com
Network Solutions, LLC
abuse@web.com
GoDaddy.com, LLC
abuse@godaddy.com
Amazon Technologies Inc.
abuse@amazonaws.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
WD Import and Export Inc.
MARCS-CMS 516144 —
February 13, 2018
Recipient:
WD Import and Export Inc.
United States
Issuing Office:
United States
Office of Regulatory Affairs
Office of Enforcement and Import Operations
Division of Northeast Imports
February 13, 2018
Mr. Chien Chen Wang, Owner
WD Import and Export, Inc.
4703 2nd Avenue
Brooklyn, NY 11232-4218
Dear Mr. Wang:
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2017-4, dated January 26, 2017. 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/
Slater K. Bartlett
Acting Compliance Officer
Division of Northeast Imports-Compliance Branch
Content current as of:
02/16/2018
CLOSEOUT LETTER
Wellington Foods
MARCS-CMS 505161 —
May 14, 2018
Recipient:
Wellington Foods
United States
Issuing Office:
United States
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild, Irvine, CA 92612
Telephone:
949-608-4496
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
May 14, 2018
Anthony E. Harnack II, President
Wellington Foods, Inc.
1930 California Ave.
Corona, CA 92881
RE: WL #11-17 Close-Out Letter
Dear Mr. Harnack:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #11-17, dated January 6, 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/
Sergio Chavez
Compliance Branch Director
Office of Human and Animal Food
Division 5 West
Content current as of:
05/18/2018
CLOSEOUT LETTER
Westar Nutrition Corp. dba: Viva Life Science, Inc.
June 13, 2018
Recipient:
Westar Nutrition Corp. dba: Viva Life Science, Inc.
United States
Issuing Office:
United States
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild, Irvine, CA 92612
Telephone: 949-608-4496
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
June 13, 2018
Emmanuel W. Fan, President/CEO
Westar Nutrition Corp. dba Viva Life Science, Inc.
350 Paularino Ave.
Costa Mesa, CA 92626
RE: WL #30-15 Close-Out Letter
Dear Mr. Fan:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #30-15, dated July 22, 2015. 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/
Sergio Chavez
Director Compliance Branch
Food and Drug Administration
HAF Division West 5
Content current as of:
06/21/2018
CLOSEOUT LETTER
Western Enterprises/Scott Fetzer Company
MARCS-CMS 441366 —
October 09, 2018
Recipient:
Recipient Name
Andrew Cheshire
Recipient Title
President
Western Enterprises/Scott Fetzer Company
Western Enterprises/Scott Fetzer Company
875 Bussett Road
Westlake
,
OH
44145
United States
ACheshire@westernenterprises.com
Issuing Office:
Center for Devices and Radiological Health
6751 Steger Drive
Cincinnati
,
OH
45237-3097
United States
(513) 679-2700
Dear Mr. Cheshire:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CIN 15-441366-03, dated October 10, 2014. 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/
Gina M. Brackett
Director Compliance Branch
Office of Medical Device and Radiological Health Operations Division 1/East
Cc: Chad Gerbick, Director, Quality and Regulatory CGerbick@WesternEnterprises.com
Content current as of:
10/10/2018