tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Eco Lips, Inc.
MARCS-CMS 631629 —
August 22, 2024
Delivery Method:
UPS Next Day Air
Product:
Drugs
Recipient:
Recipient Name
Robert P. Shriver
Recipient Title
Chief Operating Officer
Eco Lips, Inc.
6000 Huntington Ct NT
Cedar Rapids
,
IA
52402
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
Secondary Issuing Offices
United States
Dear Mr. Shriver:
The Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter #631629 dated September 20, 2022. 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/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III
Content current as of:
08/30/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
EU Natural Inc.
MARCS-CMS 605871 —
November 13, 2024
Product:
Dietary Supplements
Recipient:
Recipient Name
Vinay Amin
Recipient Title
President
EU Natural Inc.
2654 W Horizon Ridge Pkwy
Henderson
,
NV
89052
United States
info@eunatural.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Secondary Issuing Offices
United States
Dear Mr. Amin:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #605871, issued June 9, 2021. 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 Enforcement Branch
Division of Critical Foods and Dietary Supplement Enforcement
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
05/11/2026
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Euro USA, Inc.
MARCS-CMS 666173 —
September 17, 2024
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Joseph O’Donnell
Recipient Title
Chief Executive Officer
Euro USA, Inc.
4481 Johnston Parkway
Cleveland
,
OH
44128
United States
duff@eurousa.com
Issuing Office:
Division of Human and Animal Food Operations East V
United States
Secondary Issuing Offices
United States
Dear Mr. O’Donnell:
The Food and Drug Administration has completed an evaluation of Euro USA, Inc. corrective actions in response to our Warning Letter 666173, dated November 22, 2023. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Further 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/
Allison C. Hunter
Compliance Officer
Office of Human and Animal Food Operations
East 5 Division
Content current as of:
09/23/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Fischer Analysen Instrumente Gmbh
MARCS-CMS 650388 —
July 08, 2024
Product:
Medical Devices
Recipient:
Recipient Name
Dr. Martin Schaich
Recipient Title
Managing Director
Fischer Analysen Instrumente Gmbh
Brahestr. 25-27
04347
Leipzig, Saxony
Germany
Martin.Schaich@fan-gmbh.de
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Dr. Martin Schaich:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS# 650388, dated February 3, 2023). 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/
Courtney H. Lias, Ph.D. Acting Director
OHT7: Office of In Vitro Diagnostic Devices Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
US AGENT:
Philip Ross
Gulf Coast Scientific, Inc. / ARJ Medical, Inc.
209 State Street E.
Oldsmar, FL US 34677
Email: PRoss@Gulfcoastscientific.com
Content current as of:
07/15/2024
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Formology Lab Inc.
MARCS-CMS 644745 —
December 19, 2024
Reference #:
FEI 3014278936
Product:
Drugs
Recipient:
Recipient Name
Mr. Oren Ezra
Recipient Title
Owner and Chief Executive Officer
Formology Lab Inc.
9174 Deering Avenue
Chatsworth
,
CA
91311-5801
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Secondary Issuing Offices
United States
Dear Mr. Ezra:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 644745 dated March 1, 2023.
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/
Yumi Hiramine
Compliance Officer
Division of Drug Quality III
Content current as of:
12/31/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Golden Lab LLC
MARCS-CMS 625783 —
March 22, 2024
Delivery Method:
VIA Electronic Mail
Reference #:
24-HAFE4-WLCOL-05
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Dr. Howard J. Loff, M.D.
Recipient Title
Owner and CEO
Golden Lab LLC
2375 Saint Johns Bluff Rd S Ste 310
Jacksonville
,
FL
32246-2335
United States
Hloffmd@doctorsoptimalformula.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV
United States
Secondary Issuing Offices
United States
Dear Dr. Loff:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 22-HAFE4-WL-05 dated May 26, 2022. 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/
Pearl E. Lopina
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
04/03/2024
Regulated Product(s)
Drugs
Food & Beverages
CLOSEOUT LETTER
Golden Shrimp Seafood Joint Stock Company
MARCS-CMS 682535 —
August 22, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Phuc T. Vo
Recipient Title
Company Director
Golden Shrimp Seafood Joint Stock Company
Hoa Phau Hamlet, Thuan Yen Village
03, National Road 80th, Group
Ha Tien Town
Kien Giang Province
920000
Vietnam
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Secondary Issuing Offices
United States
Dear Mr. Vo,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 628535 issued May 16, 2024. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Maria Corpuz
Branch Chief
Food Adulteration and Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
11/22/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Healthtex Distributors, Inc.
MARCS-CMS 654453 —
January 31, 2024
Delivery Method:
VIA Electronic Mail
Reference #:
24-HAFE4-WLCOL-02
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Natividad R. Elias
Recipient Title
President and Owner
Healthtex Distributors, Inc.
3555 NW 41st ST.
Miami
,
FL
33142-4310
United States
ybarreto@healthtexusa.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Secondary Issuing Offices
United States
Dear Mr. Elias:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 23-HAFE4-WL-04 dated June 15, 2023. 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/
Pearl Lopina
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
03/06/2024
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Hi-Pro Feeds LLC
MARCS-CMS 667790 —
August 21, 2024
Delivery Method:
UPS Overnight
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mr. Clifton (NMI) Morgan
Recipient Title
General Manager / President
Hi-Pro Feeds LLC
1201 E. 11th Street
Friona
,
TX
79035-1410
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Secondary Issuing Offices
United States
Dear Mr. Morgan:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 667790 dated February 01, 2024) issued following an inspection of your FDA licensed medicated feed manufacturing facility, located at 1201 E 11th St. Friona, TX 79035-1410 from July 31 through August 4, 2023. 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/
Dana Lewis
Acting Director, Compliance Branch
Human & Animal Food Operations,
West Division 3
cc: Mr. Mark W. Osborn, Plant Manager
Hi-Pro Feeds, LLC
1201 E 11th St
Friona, TX 79035-1410
Cc: Mary Sasser, Program Director
Office of the Texas State Chemist
ATTN: Mary Sasser, Program Director
P.O. Box 3160
College Station, TX 77841-3160
Content current as of:
08/30/2024
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Hunan Gagazui Food Co., Ltd.
MARCS-CMS 673799 —
April 11, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Xia Wang
Recipient Title
Owner
Hunan Gagazui Food Co., Ltd.
Sanfeng Industrial Park
Huarong County
Yueyang, Hunan
414200
China
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Secondary Issuing Offices
United States
Dear: Ms. Wang:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 673799, issued February 9, 2024. 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 R. Jones
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
05/13/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Inmar Supply Chain Solutions, LLC
MARCS-CMS 666158 —
August 02, 2024
Delivery Method:
UPS Overnight
Product:
Food & Beverages
Recipient:
Recipient Name
Spencer Baird
Recipient Title
Chief Executive Officer
Inmar Supply Chain Solutions, LLC
1 W. 4th St., Suite 500
Winston-Salem
,
NC
27101
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Secondary Issuing Offices
United States
Dear Spencer Baird:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 666158 dated January 30, 2024) issued following an inspection of your facility, Inmar Supply Chain Solutions, LLC, located at 1131 W Bardin Rd. Ste 131, Arlington, TX 76017. 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/
Dana Lewis
Acting Director, Compliance Branch
Human & Animal Food Operations,
West Division 3
Cc: Mr. Donald C. Spivey, Sr. Manager Warehouse II
Inmar Supply Chain Solutions, LLC
1131 W. Bardin Rd. Ste. 131
Arlington, TX 76017
Cc: Fred Jorgenson, EVP & Chief Legal Officer
Inmar Supply Chain Solutions, LLC
1 W. 4th St., Suite 500
Winston-Salem, NC 27101
Cc: Lori Woznicki, Food and Drug Inspections Branch
Manager Division of Regulatory Services
Texas Department of State Health Services
1100 E. 49th Street – Mail Code 1987
Austin, Texas 78756
Content current as of:
11/04/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Jubilant Generics Limited
MARCS-CMS 569799 —
April 23, 2024
Reference #:
3006895982
Product:
Drugs
Recipient:
Recipient Name
Dr. Jaidev Sanjeev Rajpal
Recipient Title
Managing Director & CEO
Jubilant Generics Limited
Plot No. 15, Knowledge Park – II
Greater Noida
201306
Uttar Pradesh
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
Dear Dr. Rajpal
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-15 dated March 6, 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 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/
Marisa Heayn
Compliance Officer
Division of Drug Quality II
Content current as of:
05/01/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Kogniz, Inc.
MARCS-CMS 613569 —
August 16, 2024
Product:
Medical Devices
Recipient:
Recipient Name
Jed Putterman
Recipient Title
Co-CEO
Kogniz, Inc.
611 Gateway Boulevard
Suite 120
South San Francisco
,
CA
94080
United States
jed@kogniz.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Jed Putterman:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #613569, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.
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 in the future.
Sincerely,
/S/
for
Kellie B. Kelm, Ph.D.
Acting Director
OHT 3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
08/30/2024
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Korean Food, Inc.
MARCS-CMS 669241 —
September 23, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Sung Hee Pak
Recipient Title
Owner
Korean Food, Inc.
1311 Luke St.
Irving
,
TX
75061-4007
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Secondary Issuing Offices
United States
Dear Ms. Pak,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated January 8, 2024, issued following inspection of your facility located at 1311 Luke St., Irving, TX 75061-4007. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. If you choose to reestablish or sell 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/
Dana M. Lewis
Acting Director, Compliance Branch
Office of Human and Animal Food, WD3
Content current as of:
09/27/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Lathem Family Farms, Inc.
MARCS-CMS 660924 —
April 26, 2024
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
David L. Lathem
Lathem Family Farms, Inc.
1236 Wayne Poultry Road
Pendergrass
,
GA
30567
United States
dlathem@lathemfarms.com
Issuing Office:
Division of Human and Animal Food Operations East III
United States
Secondary Issuing Offices
United States
Dear Mr. Lathem:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated October 5, 2023. 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/
Lakisha N. Morton
Compliance Officer
Office of Human and Animal Foods/Division East 3
Office of Regulatory Affairs/U.S. Food and Drug Administration
Content current as of:
05/01/2024
Regulated Product(s)
Food & Beverages