tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
13th Floor Elevapors LLC - s
July 31, 2018
Product:
Tobacco
Recipient:
13th Floor Elevapors LLC - s
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
Chris Warkenton and Randall Dalby
13th Floor Elevapors, LLC
3303 Harbor Blvd Suite F5
Costa Mesa, CA 92626
chris@elevapors.com
randy@elevapors.com
RE: Warning Letter issued to 13th Floor Elevapors, LLC (RW1800861)
Dear Chris Warkenton and Randall Dalby:
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 Frank ‘N Vape 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 Frank ‘N Vape 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 26, 2018, May 30, 2018, July 5, 2018, and July 19, 2018, you sent FDA a response to the Warning Letter, and we held teleconferences on June 14, 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 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.
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:
Phil Daman
Daman and Associates, LLP
1455 Pennsylvania Ave, Suite 400
Washington, D.C. 20004
Phillip.daman@damanllp.com
Domains By Proxy, LLC
13thfloorelevapors.com@domainsbyproxy.com
elevapors.com@domainsbyproxy.com
GoDaddy.com, Inc.
abuse@godaddy.com
Content current as of:
08/23/2018
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
4C Foods Corp.
March 06, 2018
Recipient:
4C Foods Corp.
United States
Issuing Office:
United States
Office of Human and Animal Food Operations East
Division 1
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
March 06, 2018
Mr. John A. Celauro, President
4C Foods, Corp.
580 Fountain Avenue
Brooklyn, NY 11208-6002
Dear Mr. Celauro:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2015-49, issued on August 18, 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
03/07/2018
CLOSEOUT LETTER
7 Daze, LLC
July 31, 2018
Product:
Tobacco
Recipient:
7 Daze, LLC
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
John Lau
7 Daze, LLC
13170 Spring Street
Baldwin Park, CA  91706
info@7dazemfg.com
RE: Warning Letter issued to 7 Daze, LLC (RW1800845)
Dear John Lau:
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 Pink Sticks 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 Pink Sticks 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 July 11, 2018, July 17, 2018, and July 23, 2018, you sent FDA a response to the Warning Letter, and we held teleconferences on July 19, 2018 and July 25, 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 UPS and Electronic Mail
cc:
John Lau
7 Daze LLC
7629 Garvalia Avenue
Rosemead, CA 91770-3064
WhoIsGuard Inc.
64c7f9a8745c4e2a9391e089a1fbe8ab.protect@whoisguard.com
NameCheap Inc.
abuse@namecheap.com
Shopify Inc.
abuse@shopify.com
Content current as of:
08/23/2018
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
8937001 Canada Inc. d/b/a Chill E-Liquid
July 13, 2018
Recipient:
8937001 Canada Inc. d/b/a Chill E-Liquid
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
Lie Lu and Abbas Dattu
8937001 Canada Inc. d/b/a Chill E-Liquid
sales@chilleliquid.com
RE: Warning Letter issued to 8937001 Canada Inc. d/b/a Chill E-Liquid (RW1800859)
Dear Lie Lu and Abbas Dattu:
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
.
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.
On May 31, 2018, you sent FDA a response to the Warning Letter. 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:
Eric Heyer
Thompson Hine LLP
1919 M Street N.W.
Washington, D.C. 20036-3537
eric.heyer@thompsonhine.com
Domains By Proxy, LLC
Chilleliquid.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Amazon Technologies Inc.
abuse@amazonaws.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
ACH Group, LLC d/b/a Candy Co E-Liquids
July 13, 2018
Product:
Tobacco
Recipient:
ACH Group, LLC d/b/a Candy Co E-Liquids
United States
Issuing Office:
United States
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
July 13, 2018
VIA UPS and Electronic Mail
Allen Park
ACH Group, LLC d/b/a Candy Co E-Liquids
14946 Shoemaker Ave Ste A
Santa Fe Springs, CA 90670
candycoeliquids@gmail.com
sales@candycoeliquids.com
RE: Warning Letter issued to ACH Group, LLC d/b/a Candy Co E-Liquids(RW1800852)
Dear Allen Park:
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 Patches by Candy Co 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 Patches by Candy Co 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.
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:
Allen Park
ACH Group, LLC d/b/a Candy Co E-Liquids
10941 Hayford St
Norwalk, CA  90650
GoDaddy.com, LLC
abuse@godaddy.com
Content current as of:
08/23/2018
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Aegeia Skin Care, LLC
May 17, 2018
Product:
Cosmetics
Recipient:
Aegeia Skin Care, LLC
United States
Issuing Office:
United States
Office of Human and Animal Food Operations West Division 3
4040 North Central Expressway, Suite 300
Dallas, Texas 75204
May 17, 2018
UPS OVERNIGHT
Ms. Rebecca S. Wachsler, Owner
Aegeia Skin Care, LLC
3128 Nasa Road 1
Seabrook, TX 77586
Dear Ms. Wachsler
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2017-DAL-WL-12 dated February 17, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA surveillance and regulatory activities could 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. If you choose to reestablish or sale your operations, 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 E. Hensley
Director of Compliance Branch, OHAF-W3
Content current as of:
06/12/2018
Regulated Product(s)
Cosmetics
CLOSEOUT LETTER
Agape III
MARCS-CMS 483384 —
October 18, 2018
Recipient:
Recipient Name
Charles Crissey
Recipient Title
Owner
Agape III
Agape III
Alligator Bay Marina, Way & Bains Rd
Alligator Bay
,
Long Island
Bahamas
crisseycharles@gmail.com
Issuing Office:
United States
Dear Mr. Crissey:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 483384, issued December 10, 2015. 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/
Maria G. Corpuz, Team Leader
Food Adulteration and Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/30/2018
CLOSEOUT LETTER
Alber GmbH
July 27, 2018
Product:
Medical Devices
Recipient:
Alber GmbH
United States
Issuing Office:
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
July 27, 2018
Hansjorg Reiner
Managing Director
Alber GmbH
Vor dem Weissen Stein 21
Albstadt, Germany 722461
Dear Mr. Reiner:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS Case #532755] dated September 15, 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/
William C. MacFarland
Director
Division of Manufacturing and Quality
Office of Compliance
Center for Devices and Radiological Health
CC:
US Agent
Elijah N. Wreh
Invacare Corporation
One Invacare Way
Elyria, OH 44035
Ewreh@invacare.com
Content current as of:
08/17/2018
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
American Specialty Pharmacy
MARCS-CMS 513239 —
November 07, 2018
Delivery Method:
UPS EXPRESS
Recipient:
Recipient Name
Abdul Hameed
Recipient Title
President/Owner
American Specialty Pharmacy
American Specialty Pharmacy
13988 Diplomat Drive
Ste 100
Farmers Branch
,
TX
75234
United States
Issuing Office:
Office of Pharmaceutical Quality Operations
4040 N. Central Expressway
Suite 300
Dallas
,
TX
75204
United States
November 7, 2018
VIA UPS EXPRESS
Abdul Hameed. President/Owner
ASP Cares
13988 Diplomat Drive, Ste 100
Farmers Branch, Texas 75234
Mr. Hameed:
This letter acknowledges receipt of your letter dated April 10, 2017, in which you responded to FDA’s warning letter (ref: WL# 2017-DAL-WL-13) dated April 4, 2017. FDA acknowledges your statement that “the sterile division at 10 Medical Parkway was permanently closed [] and [your firm does not] intend to resume production of sterile drugs in the future.” We acknowledge that your firm has ceased production at the Medical Parkway facility. Therefore, there are no remaining compounding-related issues.
You are expected to take all necessary steps to assure 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 regarding this letter, you may contact me by telephone at (214) 253-5288.
Sincerely,
/S/
LCDR John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II
Content current as of:
11/13/2018
CLOSEOUT LETTER
Ami Cosmetics Co., Ltd.
July 11, 2018
Product:
Drugs
Recipient:
Ami Cosmetics Co., Ltd.
United States
Issuing Office:
United States
Center for Drug Evaluation and Research
Silver Spring, MD 20993-0002
July 11, 2018
Kyung Rok Lee
AMI Cosmetic Co.
19 Yanghwa-Ro
Mapu-Gu, Seoul KOR (Republic of Korea) 121-888
Kyung Rok Lee:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 1040, issued June 12, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA regulatory activities will further assess the adequacy and sustainability of these actions.
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 to 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/
Maria Rossana R. Cook
Director
Office of Program and Regulatory Operations
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
07/11/2018
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda
June 29, 2018
Recipient:
Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
June 29, 2018
Mr. Luiz Henrique Matiazzi, President
Apis Vida lndustria e Comercio Produtos Farmaceuticos Ltda
Rua Alcidio Pagalelli, 412
Jardim Canada
Bebedouro, Brazil 14707-016
Dear Mr. Luiz Henrique Matiazzi:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #472428, issued 8/27/2015. 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, Acting Chief
Dietary Supplement and Labeling Assessment
Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
08/14/2018
CLOSEOUT LETTER
Appel Feinkost GmbH & Co. KG
MARCS-CMS 524654 —
March 27, 2018
Recipient:
Recipient Name
Wolfgang Lucht
Recipient Title
Plant Manager
Appel Feinkost GmbH & Co. KG
Appel Feinkost GmbH & Co. KG
Neufelder Schanze 2
Cuxhaven, Lower Saxony, 27472
Germany
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740
United States
March 27, 2018
Mr. Wolfgang Lucht
Plant Manager
Appel Feinkost GmbH & KG
Neufelder Schanze 2
Cuxhaven, Lower Saxony, 27472 Germany
Dear Mr. Lucht:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #524654, issued June 1, 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/
Brandon Bridgman
Compliance Officer
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
10/03/2018
CLOSEOUT LETTER
APS BioGroup, Inc
April 05, 2018
Product:
Drugs
Recipient:
APS BioGroup, Inc
United States
Issuing Office:
United States
U.S. Food & Drug Administration
PO Box 25087
Denver, CO 80225
April 5, 2018
WARNING LETTER CLOSE-OUT
VIA UPS overnight
Mr. George Stagnitti, President & CEO
APS Biogroup, Inc.
2235 South Central Ave.
Phoenix, AZ 85004-2909
Dear Mr. Stagnitti:
The Food and Drug Administration has completed an evaluation of APS Biogroup's corrective actions in response to our Warning Letter HAF4W(DEN)-17-10-WL dated July 6, 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/
LaTonya M. Mitchell
District Director, FDA Denver District
Program Division Director
Office of Human and Animal Foods - Division IV West
Content current as of:
04/24/2018
Regulated Product(s)
Drugs