tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Natural Alchemist
MARCS-CMS 513852 —
July 03, 2018
Recipient:
Natural Alchemist
United States
Issuing Office:
United States
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
July 03, 2018
Mr. Will Claren, CEO
Natural Alchemist, Alurent Inc.
3941 Park Drive
El Dorado Hills, CA 95762
Dear Mr. Will Claren:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 513852), dated October 31, 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/
Sergio Chavez, Director of Compliance
Office Human and Animal Foods
Division West 5
Content current as of:
07/09/2018
CLOSEOUT LETTER
Nature's Health, LLC
MARCS-CMS 473487 —
July 03, 2018
Recipient:
Nature's Health, LLC
United States
Issuing Office:
United States
Denver District Office
6th Ave & Kipling St
P.O. Box 25087
Denver, CO 80225
July 3, 2018
VIA UPS Overnight
Mr. Lawrence Lim, Owner
Nature's Health LLC
2212 S West Temple, Ste. 10
Salt Lake City, UT 84115
Dear Mr. Lim:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-16-02-WL, dated December 2, 2015. 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
Program Division Director
Office of Human and Animal Food Operations -
Division IV West
Content current as of:
09/14/2018
CLOSEOUT LETTER
Navinta, LLC
MARCS-CMS 498400 —
March 05, 2018
Recipient:
Navinta, LLC
United States
Issuing Office:
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
March 5, 2018
UNITED PARCEL SERVICE
Dr. Mahendra Patel, CEO
Navinta, LLC
1499 Lower Ferry Road
Ewing, NJ 08618‐1414
Dear Dr. Patel:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated September 26, 2016 (Ref: 16‐NWJ‐16). Based on our evaluation, it appears that 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 from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its regulations or with other relevant legal authorities. The Agency expects you 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/
LaShanda Long, M.S.
Branch Chief
Postmarketing Safety Branch
Division of Enforcement and Postmarketing Safety
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Building 51, Room 5356
10903 New Hampshire Avenue
Silver Spring, MD 20993‐0002
Content current as of:
04/19/2018
CLOSEOUT LETTER
Nd Labs, Inc.
MARCS-CMS 510453 —
December 04, 2018
Delivery Method:
United Parcel Service
Recipient:
Recipient Name
Michael A. Beller
Recipient Title
Co-Owner
Nd Labs, Inc.
Nd Labs, Inc.
202 Merrick Rd.
Lynbrook
,
NY
11563
United States
Issuing Office:
Office of Human and Animal Food Operations East Division I
United States
Dear Mr. Beller:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 510453, issued on September 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
12/10/2018
CLOSEOUT LETTER
Neo Vision Co Ltd
February 20, 2018
Recipient:
Neo Vision Co Ltd
United States
Issuing Office:
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
FEB 20, 2018
Kyung-Hwa Kim
President
New Vision Co., Ltd.
129-1 Donghwagongdan-Ro, Munmak-Eup
Wonju-Si, Gangwon-Do 220801
Republic of Korea
Dear Mr. Kim:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our letter (CMS# 506797) dated September 14, 2016. Based on our evaluation, it appears that you have addressed the violations contained in the 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/
CAPT Raquel Peat, PhD, MPH
Director
Division of Premarket and Labeling Compliance
Office of Compliance
Center for Devices and Radiological Health
Cc:
US Agent
Kelly Kim
Kelly Medical Consulting
27001 La Paz Road, Suite# 314
Mission Viejo, CA 92691
Content current as of:
02/28/2018
CLOSEOUT LETTER
Neo Vision Co Ltd
MARCS-CMS 506797 —
February 20, 2018
Recipient:
Recipient Name
Kyung-Hwa Kim
Recipient Title
President
Neo Vision Co Ltd
129-1 Donghwagongdan-Ro
Munmak-Eup
Wonju-si
Gangwon-do
26361
South Korea
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Kim:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our letter (CMS# 506797) dated September 14, 2016. Based on our evaluation, it appears that you have addressed the violations contained in the 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/
CAPT Raquel Peat, PhD, MPH
Director
Division of Premarket and Labeling Compliance
Office of Compliance
Center for Devices and Radiological Health
Cc:
US Agent
Kelly Kim
Kelly Medical Consulting
27001 La Paz Road, Suite# 314
Mission Viejo, CA 92691
Content current as of:
02/28/2018
CLOSEOUT LETTER
Netcos Co., Ltd.
MARCS-CMS 565521 —
November 30, 2018
Recipient:
Recipient Name
Bae Tae-Jong
Netcos Co., Ltd.
Netcos Co., Ltd.
3/F Seocho-dong 23- 12 Hyoryeong-ro 60-Gil
Seocho-gu
Seoul
06721
South Korea
Issuing Office:
United States
Dear Bae Tae-Jong:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 1326, issued on October 29, 2018 Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and delisted the product by the way of including a marketing end date. 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:
12/04/2018
CLOSEOUT LETTER
NEwhere Inc. d/b/a Mad Hatter Juice
MARCS-CMS 548076 —
July 13, 2018
Recipient:
NEwhere Inc. d/b/a Mad Hatter Juice
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
Ali Esmaili
NEwhere Inc. d/b/a Mad Hatter Juice
19801 Nordhoff Pl #107
Chatsworth, CA 91311
info@MadHatterJuice.com
ali@newhere.com
RE: Warning Letter issued to NEwhere Inc. d/b/a Mad Hatter Juice (RW 1800836)
Dear Ali Esmaili:
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 One Mad Hit Juice Box 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 One Mad Hit Juice Box 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 10, 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
VIA UPS and Electronic Mail
cc:
VapeCo Distribution LLC
Attn: Jameson Rodgers
9301 Oakdale Ave Suite #104
Chatsworth, CA 91311
One Hit Wonder Holdings, LLC
Attn: Andrew Gale
1820 W. Orangewood Ave, Ste 104B
Orange, CA 92868
GoDaddy.com, LLC
abuse@godaddy.com
Shopify Inc.
abuse@shopify.com
Content current as of:
08/23/2018
CLOSEOUT LETTER
Nikki's Ginger Tea LLC
MARCS-CMS 446205 —
March 14, 2018
Recipient:
Nikki's Ginger Tea LLC
United States
Issuing Office:
United States
Chicago District Office
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Telephone:
(312) 353-5863
Fax:
(312) 596-4187
March 14, 2018
VIA UPS
Andrena N. Sasser, Co-Owner
Monique D. Sasser, Co-Owner
Nikki’s Ginger Tea, LLC
231 E. Grand Boulevard
Detroit, MI 48207
Dear Mses. Sasser,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 2015-DET-07, dated March 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/
Byron J. Ho, DVM
Compliance Officer
Human and Animal Food Operations
Division East 6
Content current as of:
04/16/2018
CLOSEOUT LETTER
Nomax Inc
MARCS-CMS 512566 —
August 21, 2018
Product:
Medical Devices
Recipient:
Recipient Name
Charles L. Voellinger
Recipient Title
President and CEO
Nomax Inc
9735 Green Park Industrial Drive
Saint Louis
,
MO
63123-7241
United States
clvoellinger@nomax.com
Issuing Office:
Center for Devices and Radiological Health
555 Winderley Place #200
Maitland
,
FL
32751
United States
(407) 475-4700
Dear Mr. Voellinger:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS Case: 512566), dated December 15, 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/
Blake Bevill, MS
Program Division Director
Division of Medical Devices and Radiological Health
Operations II Central
Content current as of:
09/13/2018
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Northern Fish Products, Inc.
MARCS-CMS 514554 —
February 28, 2018
Recipient:
Northern Fish Products, Inc.
United States
Issuing Office:
United States
Seattle District Office
22215 261h Avenue SE, Suite 210
Bothell, Washington 98021
February 28, 2018
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Ross R. Swanes, President
Northern Fish Products, Inc.
P.O. Box 9615
Tacoma, Washington 98409
Dear Mr. Swanes:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 17-12, dated April 25, 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:
03/05/2018
CLOSEOUT LETTER
Nova Distributors, LLC
MARCS-CMS 539670 —
February 20, 2018
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Donald E. Bruch
Nova Distributors, LLC
One Nova Way
R.R. 1 Box 52
Golden Eagle
,
IL
62036
United States
info@tarbarfilter.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Bruch:
On November 17, 2017, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter for the sale or distribution of modified risk tobacco products without an FDA order in effect that permits such sale or distribution, in violation of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
On December 21 , 2017, you sent FDA a response to the Warning Letter, and we had a teleconference on January 17, 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 Ele Ibarra-Pratt at
(301) 796-9235
or by email at
elenita.ibarrapratt@fda.hhs.gov
.
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
cc:
Azim Chowdhury
Keller and Heckman, LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
chowdhury@khlaw.com
Content current as of:
05/07/2019
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Novacyl (Thailand) Ltd.
MARCS-CMS 433932 —
May 17, 2018
Recipient:
Novacyl (Thailand) Ltd.
United States
Issuing Office:
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
May 17, 2018
Barnabe Chaize, Managing Director
321 Moo, Bangpoo Industrial Estate Soi 6 B
Praeska, Muang, Samutprakam, 10280 Thailand
Reference: FEI 3000287096
Dear Mr. Chaize:
The Food and Drug Administration (FDA) has completed an evaluation of your firm 's corretive actions in response lo our Warning Letter: #320-15-07 dated February 27, 2015. Based on our evaluation, it appears that you have addressed the deviations contained in th is Warning Letter. Future FDA inspections and rcgulutory activities will further assess the adequacy and sustainability or these correct ions.
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 stale of compliance. This letter will not preclude any future regulatory action should deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Bryce Hammer
Compliance Officer
Division of Drug Quality II
Content current as of:
06/06/2018
CLOSEOUT LETTER
Noven Pharmaceuticals, Inc.
MARCS-CMS 479136 —
April 21, 2018
Recipient:
Noven Pharmaceuticals, Inc.
United States
Issuing Office:
United States
Office of Pharmaceutical Quality Operations, Division 2
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204
April 21, 2018
VIA UPS OVERNIGHT
Mr. Jeff Mihm, President and CEO
Noven Pharmaceuticals Inc.
11960 S.W. 144th Street
Miami, Florida 33186-6109
Mr. Mihm:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (FLA-16-21) dated August 5, 2016. Based on our evaluation during the January 18, 2018 through January 26, 2018 inspection of your firm, 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.
If you have any questions regarding this letter, you may contact Jose R. Lopez at
JoseR.Lopez@fda.hhs.gov
or by phone at
(787) 729-8603
. In addition, you may contact me 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:
04/24/2018
CLOSEOUT LETTER
NutraCore Health Products
MARCS-CMS 542906 —
September 11, 2018
Product:
Drugs
Recipient:
Recipient Name
Mr. Chris Beekman
NutraCore Health Products
Nutracore Health Products
1207 Halapa Way
Trinity
,
FL
34638
United States
Issuing Office:
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
SILVER SPRING
,
MD
20993
United States
Dear Mr. Beekman:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 542906, 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