tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
DRG Instruments GmbH
MARCS-CMS 522669 —
July 01, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Dr. Bernd Rӧder
Recipient Title
Head of Regulatory Affairs
DRG Instruments GmbH
Frauenbergstraβe 18
35039
Marburg
Germany
Issuing Office:
"OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality"
United States
Dear Dr. Rӧder:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 522669, dated 10/17/2017). 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 yours,
/S/
Courtney H. Lias, Ph.D.
Deputy Director for Patient Safety and Product
Quality
OHT7: Office of In Vitro Diagnostics and
Radiological Health
Center for Devices and Radiological Health
CC:
Ina Hairston
DRG International, Inc.
841 Mountain Avenue
Springfield , NJ US 07081
Email: qa@drg-international.com
Content current as of:
07/28/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
DSM Nutritional Products, LLC
MARCS-CMS 578300 —
June 03, 2020
Delivery Method:
UPS Overnight
Product:
Animal & Veterinary
Recipient:
Recipient Name
Chris Goppelsroeder
Recipient Title
President
DSM Nutritional Products, LLC
45 Waterview Blvd.
Parsippany
,
NJ
07054
United States
Issuing Office:
Human & Animal Food Operations, West Division 3
United States
Dear Mr. Goppelsroeder:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 578300 dated October 11, 2019) issued following an inspection of your vitamin and mineral premix animal food manufacturing facility located at 5101 Rondo Dr., Fort Worth, TX 76106. 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. Havranek
Director, Compliance Branch
Human & Animal Food Operations, WD3
Cc:
Stephen J. Gristina, Director of Premix Operations – North America
DSM Nutritional Products, North America
45 Waterview Blvd.
Parsippany, NJ 07054
Lance Collard, Plant Manager
DSM Nutritional Products, LLC
5101 Rondo Drive
Fort Worth, TX 76106
Office of Texas State Chemists
Dr. Timothy Herrman
445 Agronomy Road
College Station, TX 77843
Content current as of:
06/12/2020
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Duy Drugs Inc.
MARCS-CMS 542933 —
May 27, 2020
Delivery Method:
Electronic Mail
Reference #:
20-HAFE4-WLCOL-12
Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Mr. Ricardo Mayo-Alvarez
Recipient Title
President/Owner
Duy Drugs Inc.
1730 NW 79th Ave.
Doral
,
FL
33126
United States
doralphar@aol.com
Issuing Office:
Office of Human and Animal Food Operations Division IV East
United States
(787) 729-8500
Dear Mr. Mayo-Alvarez:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 18-HAFE4-WL-05 dated August 28, 2018. 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.
Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
06/15/2020
Regulated Product(s)
Dietary Supplements
Drugs
CLOSEOUT LETTER
Earthworks Health
MARCS-CMS 560772 —
February 04, 2020
Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Dietary Supplements
Recipient:
Recipient Name
Larry D. Smith
Recipient Title
Owner
Earthworks Health
2100 N. 13th St.
Norfolk
,
NE
68701
United States
Issuing Office:
Office of Human and Animal Food Division II West
United States
913-495-5100
Dear Mr. Smith:
The Food and Drug Administration has completed an evaluation of Welter Farms Inc.
corrective actions in response to our Warning Letter (CMS case #: 560772) on June 28, 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,
/S/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
02/05/2020
Regulated Product(s)
Animal & Veterinary
Dietary Supplements
CLOSEOUT LETTER
ECIG Online Ltd d/b/a Vvapour
MARCS-CMS 597052 —
November 02, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
RW1901212
Recipient:
Recipient Name
Jonathan Matthew Hewston
ECIG Online Ltd d/b/a Vvapour
United States
info@vvapour.co.uk
inquiries@vvapour.co.uk
sales@vvapour.co.uk
Issuing Office:
Division of Promotion, Advertising, and Labeling
United States
Dear Jonathan Matthew Hewston:
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 November 26, 2019, in response to our Warning Letter dated November 26, 2019. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://vvapour.co.uk.
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
Content current as of:
11/25/2020
CLOSEOUT LETTER
Eidon Incorporated
MARCS-CMS 456914 —
March 31, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
4-16
Recipient:
Recipient Name
Robert M. Wagner
Recipient Title
President/CEO
Eidon Incorporated
12330 Stowe Dr.
Poway
,
CA
92064-6802
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Mr. Wagner:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 4-16 dated November 5, 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
04/13/2020
CLOSEOUT LETTER
ELITech Group B.V.
MARCS-CMS 534429 —
June 18, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Adriaan P. Intveld
Recipient Title
Manager Quality Assurance & Regulatory Affairs
ELITech Group B.V.
Van Rensselaerweg 4
Gelderland
6956 AV
Spankeren
Netherlands
Issuing Office:
"OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality"
United States
Dear Adriaan P. Intveld:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 534429, dated September 20, 2017). Based on our evaluation, it appears that your firm has 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 yours,
/S/
Courtney H. Lias, Ph.D.
Deputy Director for Patient Safety and Product
Quality
Office of In Vitro Diagnostics and Radiological
Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
06/12/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Evol Nutrition Associates, Inc. d/b/a Red Dawn Energy
MARCS-CMS 576309 —
February 11, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Jeremy Nickels
Evol Nutrition Associates, Inc. d/b/a Red Dawn Energy
1775 West Oak Parkway
Suite 850
Marietta
,
GA
30062
United States
Issuing Office:
Division of Enforcement
United States
Dear Mr. Nickels:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 576309, issued April 10, 2019. 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
Di vision of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
05/21/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Family Fertility Center
MARCS-CMS 588805 —
May 11, 2020
Reference #:
OBPO 19-11
Product:
Biologics
Recipient:
Recipient Name
Michele R. Birsinger
Recipient Title
Assistant Vice President
Family Fertility Center
6651 Main St.
Ste. E350
Houston
,
TX
77030-2352
United States
Issuing Office:
Office of Biological Products/Division II Compliance Branch
United States
Dear Ms. Birsinger:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter #OBPO 19-11 issued September 30, 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.
If you have any questions, please do not hesitate to contact me by phone at
(616) 233-9311
extension 1017 or by email at
Michele.Forster@fda.hhs.gov
.
Sincerely,
/S/
Michele L. Forster, PhD
Compliance Officer
Content current as of:
05/12/2020
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Flavour Warehouse LTD d/b/a Vampire Vape
MARCS-CMS 610057 —
October 01, 2020
Delivery Method:
Electronic Mail
Reference #:
RW2001417
Recipient:
Recipient Name
Philip Boyle and Nathan Walton
Flavour Warehouse LTD d/b/a Vampire Vape
United States
wholesale@vampirevape.co.uk
customerservices@vampirevape.co.uk
Issuing Office:
CTP Division of Promotion, Advertising & Labeling
United States
Dear Philip Boyle and Nathan Walton:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your email, dated September 11, 2020, in response to our Warning Letter dated September 9, 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.vampirevape.co.uk.
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
cc:
Chantelle McNeil
chantelle.mcneil@vampirevape.co.uk
Shahid Younus
Shahid.Younus@flavourwarehouse.co.uk
Flavour Warehouse LTD d/b/a Vampire Vape
Attn: Philip Boyle and Nathan Walton
contact@vampirevape.fr
orders@vampirevape.de
joe@oz-eliquid.com.au
office@esmoker.bg
info@ockglobal.com
Flavour Warehouse LTD
Attn: Philip Boyle
info@flavourwarehouse.co.uk
GoDaddy.com, LLC
abuse@godaddy.com
PSINet, Inc.
abuse@cogentco.com
Content current as of:
10/05/2020
CLOSEOUT LETTER
Flying Food Group, LLC
MARCS-CMS 581977 —
April 17, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
David Cotton
Recipient Title
CEO
Flying Food Group, LLC
212 N. Sangamon Street, #1A
Chicago
,
IL
60607
United States
Issuing Office:
Office of Human and Animal Foods- Division 3 East
60 Eighth Street N.E.
Atlanta
,
GA
30309
United States
Dear Mr. Cotton,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated August 12, 2019. Based on our evaluation during our visit on February 3-13, 2020 to your facility located at 2000 Newpoint Parkway, Suite 800, Lawrenceville, GA 30043, it appears that 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.
If you have any questions regarding this letter, you may contact Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 4600 Goer Drive, #106, North Charleston, SC 29406. You may also contact Ms. King at
(843) 746-2990
x16 or via email at
janice.king@fda.hhs.gov
.
Sincerely,
/S/
Janice L. King
Compliance Officer
U.S. Food & Drug Adminisration
Office of Human and Animal Foods- Division 3 East
(Georgia- North Carolina-South Carolina)
CC:  Christopher L. Joyner, General Manager
Flying Food Group, LLC
2000 Newpoint Parkway, Suite 800
Lawrenceville, GA 30043
Content current as of:
04/24/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Galt Pharmaceuticals LLC
MARCS-CMS 593156 —
June 03, 2020
Product:
Drugs
Recipient:
Recipient Name
Manoj Amaraneni
Recipient Title
Regulatory Affairs Officer
Galt Pharmaceuticals LLC
3350 Riverwood Parkway
Suite 1900
Atlanta
,
GA
30339
United States
Issuing Office:
Division of Advertising & Promotion Review
United States
Dear Mr. Amaraneni:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated September 13, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA surveillance 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 subsequent surveillance or through other means.
If you have any questions or comments, please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to
(301) 847-8444
. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA 51 in addition to the NDA number in all future correspondence relating to this particular matter.
Sincerely,
{See appended electronic signature page}
Christine Bradshaw, Pharm D, RAC
Regulatory Review Officer
Division of Advertising & Promotion Review 1
Office of Prescription Drug Promotion
Reference ID: 4618801
--------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
--------------------------------------------------------------------------------------------
/s/
------------------------------------------------------------
Content current as of:
06/12/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
GC Natural
MARCS-CMS 547463 —
March 31, 2020
Delivery Method:
United Parcel Service
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Chun H. Guo, Mr. Wen Z. Guo
Recipient Title
Secretary and Owner, President and Owner
GC Natural
6081 Dale St., Ste. B
Buena Park
,
CA
90621-4161
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Ms. Guo and Mr. Guo:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 547463 issued July 13, 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
04/24/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Goran Pharma Pvt Ltd
MARCS-CMS 545331 —
March 03, 2020
Reference #:
3009336980
Recipient:
Recipient Name
Mr. Hemant D. Dholakia
Recipient Title
Managing Director
Goran Pharma Pvt Ltd
GDIC-I, Bhavnagar Road
Sihor
364240
Gujarat
India
Issuing Office:
Division of Drug Quality II
United States
Dear Mr. Dholakia:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 320-18-48 dated April 24, 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/
Rokhsana Safaai-Jazi
Compliance Officer
Division of Drug Quality II
Content current as of:
08/05/2020