tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Hans Kissle Company, LLC
MARCS-CMS 584080 —
January 07, 2021
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Scott Moffitt
Recipient Title
CEO
Hans Kissle Company, LLC
9 Creek Brook Dr
Haverhill
,
MA
01832-1548
United States
Issuing Office:
Division of Human and Animal Food Operations East I (HAFE1)
United States
Dear Mr. Moffitt:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 584080, issued on September 24, 2019. 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:
01/15/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Heavenly Natural Products
MARCS-CMS 607470 —
January 28, 2021
Product:
Dietary Supplements
Recipient:
Heavenly Natural Products
100 Monroe St #406
Centerton
,
AR
72719
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
To Whom It May Concern:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 607470, issued December 2, 2020. 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 Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
02/01/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Henan Lihua Pharmaceutical Co., Ltd.
MARCS-CMS 548089 —
August 12, 2021
Reference #:
FEI 3001164052
Product:
Drugs
Recipient:
Recipient Name
Mr. Nui Zhigang
Recipient Title
General Manager
Henan Lihua Pharmaceutical Co., Ltd.
Middle of Huanghe Street
Anyang Shi
Henan Sheng
,
455000
China
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Zhigang:
The food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-18-58 dated June 12, 2018.
Based on our evaluation, it appears that you have addressed the 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 and will continue to monitor your state 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/
Kevin Maguire
Compliance Officer
Division of Drug Quality II
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research, FDA
Content current as of:
08/23/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Hina Singh Enterprises, Inc. d/b/a Just Eliquids Distro Inc.
MARCS-CMS 608444 —
June 25, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001358
Product:
Tobacco
Recipient:
Recipient Name
Hina Singh and Nick Trivedi
Hina Singh Enterprises, Inc. d/b/a Just Eliquids Distro Inc.
109 W. Hillsboro Blvd.
Deerfield Beach
,
FL
33441-3431
United States
dustyn@justeliquids.com
justeliquids@gmail.com
hseiboca@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Hina Singh and Nick Trivedi:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated July 20, 2020. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.justeliquids.com.
However, our surveillance shows you continue to offer for sale to customers in the United States other tobacco products that may be subject to market authorization requirements. FDA encourages you to discuss with your suppliers the current status of any particular tobacco product’s marketing application or any product’s marketing authorization. For additional information regarding currently marketed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement, please visit our website
https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-lists?utm_medium=email&utm_source=govdelivery#list%20of%20deemed
.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic 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.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
Hina Singh Enterprises, Inc. d/b/a Just Eliquids Distro Inc.
Attn: Hina Singh and Nick Trivedi
7200 NW 51st Terrace
Coconut Creek, FL 33073
Hina Singh Enterprises, Inc. d/b/a Just Eliquids Distro Inc.
Attn: Hina Singh and Nick Trivedi
140 Glades Rd.
Boca Raton, FL 33432
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
07/06/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Humble Juice Co. LLC
MARCS-CMS 583547 —
April 09, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW1901097
Product:
Tobacco
Recipient:
Recipient Name
Daniel Clark
Humble Juice Co. LLC
9400 Lurline Ave
Unit B-1
Chatsworth
,
CA
91311
United States
daniel@humblejuiceco.com
info@humblejuiceco.com
Issuing Office:
Center for Tobacco Products
United States
Dear Daniel Clark:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your response dated June 20, 2019, in response to our Warning Letter dated June 7, 2019. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding the Instagram account of Parker Hornday (pvrkerr), https://www.instagram.com/pvrkerr, containing social media posts with labeling and/or advertising for e-liquid products on behalf Humble Juice Co. LLC, as well as the Instagram account of Humble Juice Co. LLC (https://www.instagram.com/humblejuiceco), the Facebook account for Humble Juice Co. LLC (https://www.facebook.com/humblejuiceco), the Twitter account for Humble Juice Co. LLC (https://twitter.com/HumbleJuiceCo), and the website https://www.humblejuiceco.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic 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.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
Attn: Will Woodlee
wwoodlee@kkblaw.com
Content current as of:
04/26/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Hype City Vapors
MARCS-CMS 583025 —
April 09, 2021
Delivery Method:
UPS and Electronic Mail
Reference #:
RW1901098
Product:
Tobacco
Recipient:
Recipient Name
Julian Violé
Hype City Vapors
29020 Old Carriage Court
Agoura Hills
,
CA
91301-1622
United States
sales@hypecityvapors.com
Issuing Office:
Center for Tobacco Products
United States
Dear Julian Violé:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your response dated June 17, 2019, in response to our Warning Letter dated June 7, 2019. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding the Facebook account of Jay Shrek (@jasonshrek), https://www.facebook.com/jasonshrek containing social media posts with labeling and/or advertising for e-liquid products on behalf of Hype City Vapors, LLC, as well as the website https://hypecityvapors.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, & Cosmetic 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.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
04/14/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
I. Shay Cosmetics Inc
MARCS-CMS 552754 —
December 29, 2021
Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Mr. Mehdi Ehsan
Recipient Title
President/CEO
I. Shay Cosmetics Inc
1024 E Del Amo Blvd
Carson
,
CA
90746-3520
United States
nick@ishaycosmetics.com
Issuing Office:
San Francisco District Office
United States
Dear Mr. Mehdi:
The U.S. Food and Drug Administration has completed an evaluation of your corrective actions in response to our warning letter (Ref CMS 552754) dated October 29, 2018. Based on our evaluation, it appears that you have adequately 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. It is your responsibility to maintain compliance and we 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.
We have concluded that the inspection conducted from November 27, 2017 to December 7, 2017 to be “closed” under 21 CFR 20.64(d)(3), and we are enclosing a copy of the narrative portion of the Establishment Inspection Report (EIR). It may reflect redactions made by FDA in accordance with the Freedom of Information Act (FOIA) and 21 CFR part 20. This, however, does not preclude you from requesting additional information under FOIA.
It is your responsibility to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and the 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 LCDR Rumany Penn, Compliance Officer, via telephone 949-608-4409 or email Rumany.Penn@fda.hhs.gov.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
04/08/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Ideal Implant Incorporated
MARCS-CMS 606103 —
July 15, 2021
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Robert S. Hamas, MD
Recipient Title
CEO and President
Ideal Implant Incorporated
14881 Quorum Drive
Suite 925
Dallas
,
TX
75254
United States
rhamas@idealimplant.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Hamas:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated May 14, 2020. 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/
Jessica Mu,
Director, Compliance Branch
Office of Medical Devices and
Radiological Health, Division III
Content current as of:
07/21/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Immusist, LLC
MARCS-CMS 610053 —
February 26, 2021
Delivery Method:
Overnight Delivery
Product:
Dietary Supplements
Recipient:
Recipient Name
James P. Gates
Recipient Title
Managing Member
Immusist, LLC
4810 Point Fosdick Drive NW
Suite 330
Gig Harbor
,
WA
98335
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
Dear Mr. Gates:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 610053, dated October 15, 2020. 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:
03/11/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Indus Medicare Limited
MARCS-CMS 606159 —
February 17, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Pingle Janardhan Reddy
Recipient Title
Managing Director
Indus Medicare Limited
Sy No. 129, NH-44, Ramaipally Village
Manoharabad Mandal
Medak District
502336
Telangana
India
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Pingle Janardhan Reddy:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #606159, dated May 4, 2020). 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 yours,
/S/
Sharon M. Andrews
Director
DHT3B: Division of Reproductive,
Gynecology and Urology Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Bill Taffs
Eagle TWE Inc.,
4761 Hugh Howell Road, Unit M
Tucker, Georgia 30084
Email: Bill@Eagletwe.com
Content current as of:
02/14/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Innovative Medicine LLC
MARCS-CMS 607721 —
March 19, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Caspar Szulc
Innovative Medicine LLC
37-18 Northern Boulevard
Suite 202
Long Island City
,
NY
11101
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Szulc:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 607721, issued November 17, 2020. 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 Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
03/26/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Irvin, Inc.
MARCS-CMS 612738 —
September 27, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Denise Cannon
Recipient Title
President
Irvin, Inc.
3542 Pineville-Rock Hill Rd (SC Hwy 51)
Fort Mill
,
SC
29715
United States
info@theirvincorp.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Ms. Cannon:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 612738, May 27, 2021). 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 yours,
/S/
Donna Engleman, MS, BSN
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
09/27/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Jelliffe Dairy Farm
MARCS-CMS 566246 —
May 17, 2021
Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mr. & Mrs. Jelliffe
Jelliffe Dairy Farm
221 Cemetery Road
Asbury
,
NJ
08802-1402
United States
Issuing Office:
Baltimore District Office
United States
Dear Mr. & Mrs. Jelliffe,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 566246, dated November 19, 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 D. Weber
Compliance Officer
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
05/24/2021
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Jiangsu JDC Medical Devices Co., Ltd.
MARCS-CMS 598340 —
May 20, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Qing (Michael) Yang
Jiangsu JDC Medical Devices Co., Ltd.
No. 8, Jing 8 Road, Lianyun Development Zone
Lianyungang, Jiangsu
222047
China
Issuing Office:
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, Office of Product Evaluation and Quality
United States
Dear Mr. Yang:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 598340, dated December 16, 2019). 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 yours,
/S/
Courtney H. Lias, Ph.D.
Acting Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Fiona Chan
SUNGO Technical Service Inc.
6050 W. Eastwood Avenue, Apt. 201
Chicago, Illinois 60630
Content current as of:
05/24/2021
Regulated Product(s)
Medical Devices