tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Brand New Energy, LLC
June 27, 2018
Recipient:
Brand New Energy, LLC
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
June 27, 2018
Mr. Darren Housholder
Brand New Energy, LLC
3424 West Magnolia Boulevard
Burbank, CA 91505
Dear Mr. Housholder:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 447545, issued April 24, 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:
07/17/2018
CLOSEOUT LETTER
Bridgewater Resources, LLC
MARCS-CMS 541081 —
December 06, 2018
Delivery Method:
UPS Overnight
Recipient:
Recipient Name
Robert W. Runkle, Betty R. Runkle
Recipient Title
Owners
Bridgewater Resources, LLC
Bridgewater Resources, LLC
334 Main Street
Liberty
,
TX
77575
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 3
4040 N. Central Expressway
Suite 300
Dallas
,
TX
75204
United States
Dear Mr., and Mrs. Robert Runkle:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (case 541081, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Jessica E. Hensley
Director, Compliance Branch
Human & Animal Food Operations, WD3
Content current as of:
12/18/2018
CLOSEOUT LETTER
Bush Brothers & Company
May 07, 2018
Recipient:
Bush Brothers & Company
United States
Issuing Office:
United States
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
May 7, 2018
Michael T. Smith, Director of Operations
Bush Brothers and Company
3304 Chestnut Hill Road
Dandridge, Tennessee 37725-2669
Dear Mr. Smith:
The Food and Drug Administration (FDA) completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 535494. Based on our evaluation, it appears 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/
Kimberly A. Dutzek
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East
Content current as of:
05/14/2018
CLOSEOUT LETTER
Caliber Imaging & Diagnostics, Inc.
MARCS-CMS 431658 —
November 06, 2018
Product:
Medical Devices
Recipient:
Recipient Name
L. Michael Hone
Recipient Title
Chief Executive Officer
Caliber Imaging & Diagnostics, Inc.
50 Methodist Hill Drive
Suite 1000
Rochester
,
NY
14623
United States
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Hone:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS# 431658) dated January 8, 2015. Based on our evaluation, it appears that your firm has 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 yours,
/S/
For Anne M. Ferriter
Director, Division of Analysis and Program
Operations
Office of Compliance
Center for Devices and Radiological Health
cc:
Kristin Davenport
Covington & Burling LLP
One CityCenter, 850 Tenth Street, NW
Washington, DC 20001
Content current as of:
11/16/2018
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Caviar Petrossian S. A.
MARCS-CMS 560520 —
September 21, 2018
Recipient:
Recipient Name
Armen Petrossian
Recipient Title
Chief Executive Officer
Caviar Petrossian S. A.
Caviar Petrossian S. A.
Porte 47 Cap18 Voie A
43 rue de L’Evangile
75018
Paris
France
Issuing Office:
United States
Dear Mr. Petrossian:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #560520, issued August 2, 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
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/09/2018
CLOSEOUT LETTER
Celltrion Inc.
MARCS-CMS 534262 —
September 17, 2018
Reference #:
FEI 3005241015
Product:
Drugs
Recipient:
Recipient Name
Woo Sung Kee
Recipient Title
Vice-Chairman / CEO
Celltrion Inc.
23 Academy-ro
Yeonsu-gu
Incheon
22014
South Korea
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Mr. Kee,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-18-28 issued on January 26, 2018. 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 FDA 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/
Lixin (Leo) Xu, M.D., Ph.D.
Compliance Officer
Global Compliance Branch 2 (GCB2)
Division of Drug Quality I (DDQI)
Office of Manufacturing Quality (OMQ)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)
Content current as of:
02/08/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Center for Reproductive Health Joliet IVF LLC
April 09, 2018
Recipient:
Center for Reproductive Health Joliet IVF LLC
United States
Issuing Office:
United States
Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
April 09, 2018
R. Scott Springer, DO, Medical Director
Center for Reproductive Health Joliet IVF LLC
2246 Weber Rd.
Crest Hill, IL 60403
Dear Dr. Springer,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, WL #OBPO 17-01 issued July 06, 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/
Sam Labinjo
Compliance Officer
U.S. Food and Drug Administration
Office of Biological Products Operations
Division II, Compliance Branch
Tel: 312-596-4254
Samuel.Labinjo@fda.hhs.gov
Content current as of:
04/20/2018
CLOSEOUT LETTER
Central Plains Milling, LLC
April 26, 2018
Recipient:
Central Plains Milling, LLC
United States
Issuing Office:
United States
Office of Human and Animal Food –
West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100
April 26, 2018
DELIVERY VIA UPS
WARNING LETTER CLOSE-OUT LETTER
Randy Robeson, President/General Manager
Central Plains Milling LLC
211 South Lincoln
Brainard, NE 68626
Dear Mr. Robeson:
The Food and Drug Administration has completed an evaluation of Central Plains Milling corrective actions in response to our Warning Letter (CMS case #: 482837) on March 26, 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/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
05/02/2018
CLOSEOUT LETTER
Chaotic Labz
September 11, 2018
Recipient:
Chaotic Labz
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
September 11, 2018
Cordy Hooten
Chaotic Labz
220 Hankins Drive
Atkins, AR 72823
Dear Mr. Hooten:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter Re: 491536, issued March 31, 2016. Based on our evaluation, it appears you have addressed the violation(s) contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
09/12/2018
CLOSEOUT LETTER
Choice Detox Center, Inc. dba Nofeel
MARCS-CMS 543456 —
September 11, 2018
Product:
Drugs
Recipient:
Recipient Name
Mr. Kenneth Nersten
Choice Detox Center, Inc. dba Nofeel
Choice Detox Center, Inc. dba Nofeel
552 Hamilton Street
Suite E-1
Costa Mesa
,
CA
92627
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740
United States
September 11, 2018
Dear Mr. Nersten:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 543456, issued January 11, 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/
Carrie Lawlor Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/15/2018
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Citrus Fit
May 09, 2018
Recipient:
Citrus Fit
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 9, 2018
UPS OVERNIGHT
Raul Lopez Jr., Owner,
Citrus Fit Weight Loss and Detox Products, LLC
900E. Vermont Ave.
Apt. 19201
McAllen, TX 78503-1716
Dear Mr. Lopez
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2015-DAL-WL-01, dated October 15, 2014. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA surveillance 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:
05/14/2018
CLOSEOUT LETTER
On Cloud Vape
MARCS-CMS 548412 —
July 13, 2018
Recipient:
On Cloud Vape
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
Jin Back
On Cloud Vape
808 Western Ave Suite 101
Los Angeles, CA 90005
oncloudvape@outlook.com
RE: Warning Letter issued to On Cloud Vape (RW1800845)
Dear Jin Back:
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 Candy King Batch and Candy King Sour Worms e-liquid products are misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because their labeling and/or advertising is false or misleading
.
The Warning Letter also informed you that these products are misbranded under section 903(a)(7)(B) because you sold
them 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 Candy King Batch and Candy King Sour Worms e-liquids is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the products 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 Candy King Batch and Candy King Sour Worms e-liquids from your website.
On May 3, 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 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 UPS and Electronic Mail
cc:
Jin Back
341 S. Kenmore Ave. Apt. 121
Los Angeles, CA 90020
jin.k.back@outlook.com
Godaddy.com, LLC
abuse@gdaddy.com
Site Group Chicago
abuse@siteground.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
Clouded Minds Vape Shoppe
MARCS-CMS 557861 —
October 18, 2018
Delivery Method:
Electronic Mail
Reference #:
RW1800913
Recipient:
Recipient Name
Anton Snegiroff and Alexander Kovalev
Clouded Minds Vape Shoppe
Clouded Minds Vape Shoppe
United States
info@cloudedmindsvape.com, MR.SCORP666@gmail.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Anton Snegiroff and Alexander Kovalev:
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 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 September 12, 2018, you sent FDA a response to the Warning Letter, and we held a teleconference on October 3, 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 re levant 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/
Elle Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
U.S. Food & Drug Administration
Center for Tobacco Products
VIA Electronic Mail
cc:
GoDaddy.com, LLC
abuse@godaddy.com
VPS Datacenter, LLC
securitv@vpsdatacenter.com
Content current as of:
10/23/2018
CLOSEOUT LETTER
Coenzyme A, Inc.
MARCS-CMS 540210 —
November 06, 2018
Delivery Method:
Overnight Delivery
Recipient:
Recipient Name
Nickolaos D. Skouras
Recipient Title
President
Coenzyme A, Inc.
Coenzyme A, Inc.
12512 Beverly Park Road
Suite B1
Lynnwood
,
WA
98087
United States
Issuing Office:
22215 25th Avenue SE
Suite 210
Bothell
,
WA
98021
United States
Dear Mr. Skouras:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 540210, dated January 5, 2018. 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:
11/13/2018