tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Arcadia Trading Inc.
February 16, 2018
Product:
Food & Beverages
Recipient:
Arcadia Trading Inc.
United States
Issuing Office:
United States
Office of Regulatory Affairs
Office of Enforcement and Import Operations
Division of Northeast Imports
February 16, 2018
Mr. Chris Yu, President and Owner
Arcadia Trading, Inc.
1101 Metropolitan Avenue
Brooklyn, NY 11211
Dear Mr. Yu:
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2016-44, dated September 14, 2016. 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
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Armada Nutrition
March 13, 2018
Recipient:
Armada Nutrition
United States
Issuing Office:
United States
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
VIA Email
March 13, 2018
Mr. Brent A. Laffey, President
Armada Nutrition, LLC
4637 Port Royal Rd.
Spring Hill, TN 37174-2834
The Food and Drug Administration (FDA) has completed an evaluation of your firm 's corrective actions in response to our Warning Letter 523876 dated August 1, 2017. Based on our evaluation, it appears that you have addressed the violations and/or deviations 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 FDA expects you and your firm to maintain compliance with current good manufacturing practices and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations and/or deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Stephen J. Rabe
Compliance Officer
Content current as of:
03/19/2018
CLOSEOUT LETTER
Aspen Valley Vapes
MARCS-CMS 563210 —
October 26, 2018
Delivery Method:
UPS and Electronic Mail
Recipient:
Recipient Name
Andrew Flynn
Aspen Valley Vapes
14 Inverness Drive East
Suite B132
Englewood
,
CO
80112
United States
aflynn@aspenvalleyvapes.com
info@aspenvalleyvapes.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Andrew Flynn:
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 Whip'd Strawberry 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 Whip'd Strawberry 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 19, 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. 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:
GoDaddy.com, LLC
abuse@godaddy.com
Rackco.com
abuse@rackco.com
Content current as of:
03/28/2019
CLOSEOUT LETTER
Atum Do Brasil Captura Industria e Comercio
MARCS-CMS 491504 —
October 17, 2018
Reference #:
491504
Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Mr. Mauro Lucio Pecanha de Almeida
Recipient Title
President
Atum Do Brasil Captura Industria e Comercio
Atum Do Brasil Captura Industria e Comercio
Rua Sebastiao Alves de Almeida, No. 469
Praia de Itaoca
Itapemirim
-
Brazil
Issuing Office:
Public Health Service
United States
5001 Campus Drive
College Park, MD 20740
October 17, 2018
Mr. Mauro Lucio Pecanha de Almeida
President
Atum Do Brasil Captura Industria e Comercio
Rua Sebastiao Alves de Almeida, No. 469
Praia de Itaoca
Itapemirim, Brazil
Dear Mr. Pecanha de Almeida:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 491504, issued March 18, 2016. 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:
10/17/2018
Regulated Product(s)
Food & Beverages
Seafood/Seafood Product
CLOSEOUT LETTER
Azuma Foods (Suzhou) Co. Ltd.
May 24, 2018
Product:
Food & Beverages
Recipient:
Azuma Foods (Suzhou) Co. Ltd.
United States
Issuing Office:
United States
College Park, MD 20740
May 24, 2018
Norimitsu Suzuki, Trading Department
Azuma Foods (Suzhou) Co. Ltd.
No. 195 Putuoshan Road, SND
Suzhou, Jiangsu, China 215163
Dear Mr. Suzuki:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 544079 issued January 30, 2018. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Robyn Jones,
Supervisory Consumer Safety Officer
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
08/02/2018
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Balfego and Balfego, SL
February 09, 2018
Recipient:
Balfego and Balfego, SL
United States
Issuing Office:
United States
College Park, MD 20740
February 9, 2018
Begonya Melich, Director of Technical Services
Balfego and Balfego, S.L.
Poligono Industrial Edificio Balfego
Tarragona Provence
L'ametlla De Mar, Spain 43860
Dear Begonya Melich:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 442297, issued November 14, 2014. 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:
02/12/2018
CLOSEOUT LETTER
Bellus Medical
August 16, 2018
Product:
Medical Devices
Recipient:
Bellus Medical
United States
Issuing Office:
United States
Office of Medical Device and Radiological Health Operations
Division 3West
19701 Fairchild
Irvine, CA 92612
August 16, 2018
CMS: 495955
UPS Overnight
Joseph L. Proctor, President/CEO
Bellus Medical, LLC.
4505 Excel Parkway, Suite #100
Addison, Texas 75001
Dear Mr. Proctor:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2016-DAL-WL-34, dated September 13, 2016. 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/
Kelly D. Sheppard
Director, Compliance Branch
Content current as of:
08/17/2018
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Best Bentonite
MARCS-CMS 494502 —
November 23, 2018
Delivery Method:
UPS NEXT DAY DELIVERY
Reference #:
2016-DAL-WL-26
Product:
Drugs
Recipient:
Recipient Name
Marshall A. Dunlap
Recipient Title
Owner
Best Bentonite
Best Bentonite
11650 Otis Rd
Guthrie
,
OK
73044
United States
Issuing Office:
United States
Marshall A. Dunlap - Owner
Best Bentonite
11650 Otis Rd
Guthrie, OK 73044
Mr. Dunlap:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 2016-DAL-WL-26 dated June 17, 2016. Based on our evaluation during, it appears that you have addressed the violations contained in this Warning Letter related to your marketing of Best Bentonite. 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 John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
11/30/2018
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Better Body Sports LLC
June 27, 2018
Recipient:
Better Body Sports LLC
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
June 27, 2018
Mr. Jason Vaught
Better Body Sports, LLC
326 Burl Ave
Ventura, CA 93003
Dear Mr. Vaught:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 456726, issued April 22, 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 Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/25/2018
CLOSEOUT LETTER
Bhavani Fruits and Vegetables LLC
May 31, 2018
Product:
Food & Beverages
Recipient:
Bhavani Fruits and Vegetables LLC
United States
Issuing Office:
United States
Office of Human and Animal Food Operations East
Division 1
May 31, 2018
Mr. Mukund N. Patel, President/Co-Owner
Mrs. Chhaya Patel, Vice-President/Co-Owner
Bhavani Fruits and Vegetables LLC
5620 56th Street
Maspeth, NY 11378-1132
Dear Mr. and Mrs. Patel:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CMS # 541761 dated March 16th, 2018. 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
06/04/2018
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Bio-Botanica, Inc.
MARCS-CMS 370519 —
December 10, 2018
Recipient:
Recipient Name
Frank D’Amelio, Jr.
Recipient Title
President
Bio-Botanica, Inc.
Bio-Botanica, Inc.
85 Commerce Drive
Hauppauge
,
NY
11788
United States
Issuing Office:
United States
Dear Mr. D’Amelio:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-DO 2013-20 dated May 29, 2013 issued to Nature’s Answer, a subsidiary of Bio-Botanica, Inc. 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/
CDR Catherine M. Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East – Division 1
Content current as of:
12/18/2018
CLOSEOUT LETTER
BioStar Technology International, LLC
MARCS-CMS 512757 —
December 14, 2018
Delivery Method:
United Parcel Service
Reference #:
WL #24-17 Close-Out Letter
Recipient:
Recipient Name
Ulysses L. Sheretov
Recipient Title
President
BioStar Technology International, LLC
BioStar Technology International, LLC
2912 Colorado Blvd
Los Angeles
,
CA
90041
United States
Issuing Office:
United States
Dear Mr. Sheretov:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter WL # 24-15 issued April 17, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Compliance Branch Director
Office of Human and Animal Food
Division of Human and Animal FeedWest 5
Content current as of:
02/04/2019
CLOSEOUT LETTER
BioTE Medical
May 03, 2018
Recipient:
BioTE Medical
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
May3, 2018
UPS OVERNIGHT
Dr. Gary S. Donovitz, Principal-Owner & Chairman
BioTe Medical, LLC
1875 W. Walnut Hill Lane, Suite 100
Irving, Texas 75038
Dear Dr. Donovitz:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2017-DAL-WL-19 dated May 22, 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. 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:
05/07/2018
CLOSEOUT LETTER
Bluegrass Proteins, Inc.
MARCS-CMS 533552 —
December 19, 2018
Recipient:
Recipient Name
Hoyt Huffman
Recipient Title
Chief Executive Officer
Bluegrass Proteins, Inc.
Puris Proteins, Inc.
1117 Cleveland Avenue
Glasgow
,
KY
42141
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
(612) 334-4100
Dear Mr. Huffman:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 533552 dated October 26, 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/
Demetria L. Lueneburg
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
03/25/2019
CLOSEOUT LETTER
BrainAlert, LLC
April 27, 2018
Recipient:
BrainAlert, LLC
United States
Issuing Office:
United States
Seattle District Office
22215 261h Avenue SE, Suite 210
Bothell, Washington 98021
April 27, 2018
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
Jared K. Lykken, Distributing Agent
BrainAlert, LLC
3116 1641h Street SW, Unit #1106
Lynnwood, Washington 98087
Dear Mr. Lykken:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 535653, dated December 14, 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/
Miriam R. Burbach
District Director
Program Division Director
Content current as of:
05/08/2018