tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Torrent Pharmaceuticals Limited
MARCS-CMS 585255 —
September 04, 2024
Reference #:
FEI 3005029956
Product:
Drugs
Recipient:
Recipient Name
Mr. Jinesh Shah
Recipient Title
Director and Board of Director
Torrent Pharmaceuticals Limited
Taluka-Kadi, Ahmedabad Mehsana Highway
Indrad
382721
Gujarat
India
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Shah:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-03 dated October 8, 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 or 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:
09/06/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Tova Industries, LLC
MARCS-CMS 693241 —
November 18, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Zack Melzer
Recipient Title
President
Tova Industries, LLC
2902 Blankenbaker Rd.
Jeffersontown
,
KY
40299-3841
United States
zmelzer@tovaindustries.com
Issuing Office:
Human Foods Program
United States
Secondary Issuing Offices
United States
Dear Mr. Zachery Melzer:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 693241, issued October 29, 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/
William Rennells
Acting Branch Chief
Conventional Foods #2
Office of Compliance and Enforcement
The Human Foods Program
Content current as of:
12/03/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Trang Thuy Seafood Co., LTD
MARCS-CMS 668434 —
January 04, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Trang Nguyen
Recipient Title
Owner and Director
Trang Thuy Seafood Co., LTD
Lot A 12 An Phu Industrial Zone
Tuy Hoa
Phu Yen Province
Vietnam
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Secondary Issuing Offices
United States
Dear Mr. Nguyen:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #668434, issued November 3, 2023. 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
Team Leader
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
03/06/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
U S Gulf Coast Trading Co., Inc.
MARCS-CMS 668767 —
July 11, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Abdallah K. Yassir
Recipient Title
Managing Partner and Co-Owner
U S Gulf Coast Trading Co., Inc.
14100 Auto Park Way Ste. I
Houston
,
TX
77083-6656
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Secondary Issuing Offices
United States
Dear Mr. Yassir,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated December 5, 2023, issued following inspection of your facility located at 14100 Auto Park Way, Suite I, Houston, TX 77083-6656. 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 Lewis
Acting Director, Compliance Branch
Office of Human and Animal Food, WD3
Content current as of:
07/17/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Ultra Seal Corporation
MARCS-CMS 624650 —
September 25, 2024
Reference #:
FEI 1317759
Product:
Drugs
Recipient:
Recipient Name
Mr. Michael P. Borrello
Recipient Title
Executive VP of Operations
Ultra Seal Corporation
521 Main St,
New Paltz
,
NY
12561
United States
Issuing Office:
Office of Pharmaceutical Quality Operations
United States
Secondary Issuing Offices
United States
Dear Mr. Borrello:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 624650 dated March 14, 2022.
Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter pertaining to Ultra Seal Corporation FEI 1317759. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. The other two facilities cited in the Warning Letter, ULTRAtab Laboratories Inc. FEI 3003068822 and ULTRAtab Laboratories Inc., FEI 3016117472, will remain in official action indicated (OAI) status (as indicated in the correspondence dated December 8, 2023, and January 7, 2022, respectively).
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/
Craig W. Swanson
Deputy Program Division Director
OPQO Division I
Cc:
Ms. Katherine DeHaven
Regulatory Affairs Specialist
Ultra Seal Corporation
521 Main Street
New Paltz, NY 12561
Content current as of:
09/27/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
UMZU, LLC
MARCS-CMS 611501 —
September 25, 2024
Delivery Method:
Via Email
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Michael J. Dobson
Recipient Title
CEO
UMZU, LLC
6325 Spine Rd
Boulder
,
CO
80301-3321
United States
quality@umzu.com
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
Secondary Issuing Offices
United States
Dear Mr. Dobson:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS Case # 611501, dated October 14, 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 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/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
Content current as of:
10/01/2024
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Vi-Jon, LLC
MARCS-CMS 622087 —
March 08, 2024
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Mr. Richard Koulouris
Recipient Title
Chairman and CEO
Vi-Jon, LLC
Consumer Product Partners, LLC
8800 Page Avenue
St. Louis
,
MO
63114
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
Secondary Issuing Offices
United States
Dear Mr. Koulouris:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS # 622087], dated March 31, 2022. Based on our evaluation, it appears that you have adequately 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 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:
03/15/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Vitang Technology LLC
MARCS-CMS 653455 —
July 23, 2024
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Ronald Jiang
Recipient Title
Owner & CEO
Vitang Technology LLC
14622 Franklin Ave Ste H
Tustin
,
CA
92780-7224
United States
info@vitangtechnology.com
ron@vitangtechnology.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dr. Mr. Jiang,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to Warning Letter #653455 dated 6/12/2023. 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/
Jessica Mu
Compliance Branch Director
Office of Medical Devices and Radiological Health Operations
Division 3/West
Content current as of:
07/31/2024
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Wello, Inc.
MARCS-CMS 664806 —
October 22, 2024
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Alan C. Heller
Recipient Title
President/CEO
Wello, Inc.
15960 Midway Road
Addison
,
TX
75001-4280
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. Heller:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 664806, dated November 8, 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/
RDML Sean Boyd
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Content current as of:
10/28/2024
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
World Nutrition, Inc.
MARCS-CMS 610003 —
September 26, 2024
Delivery Method:
Via Email
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Thomas Miano
Recipient Title
President
World Nutrition, Inc.
15207 N 75th St, Ste 107
Scottsdale
,
AZ
85260
United States
TomMiano@WorldNutrition.net
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
Secondary Issuing Offices
United States
Dear Mr. Miano:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS Case # 610003, dated October 27, 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/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
Content current as of:
10/02/2024
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Zen Enterprises LLC
MARCS-CMS 678407 —
September 11, 2024
Product:
Drugs
Recipient:
Recipient Name
David Makima
Zen Enterprises LLC
9061 W. Sahara Ste 105
Las Vegas
,
NV
98117-5797
United States
Registration@fdaimports.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
Dear Mr. Makima:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2644. Based on our evaluation, you have discontinued Zen Sports Balm, NDC 73048-000, Zen Hemp Balm, NDC 73048-001, Zen Hand Sanitizer, NDC 73048-002, and Sycuan Casino Resort Hand Sanitizer, NDC 73048-003 by adding end marketing dates to each listing data, thus this warning letter is closed. Future FDA 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 this product is reintroduced in U.S. commercial distribution, FDA expects that all previous errors are corrected. 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/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Content current as of:
09/17/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
ADM Animal Nutrition
MARCS-CMS 657846 —
February 14, 2025
Delivery Method:
VIA EMAIL WITH READ RECEIPT: NO HARD COPY TO FOLLOW
Product:
Animal & Veterinary
Recipient:
Recipient Name
Kyle J. Dieter
Recipient Title
Plant Manager
ADM Animal Nutrition
1200 Mcgrath Ave
Effingham
,
IL
62401-4231
United States
kyle.dieter@adm.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Secondary Issuing Offices
United States
Dear Mr. Dieter,
The United States Food and Drug Administration has completed evaluation of your facility’s corrective actions in response to our Warning Letter CMS 657846, dated October 23, 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 facility 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 facility 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 Kelli L. Wilkinson
Branch Chief, Compliance Action Branch
Division of Food Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Content current as of:
08/12/2025
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Ambu USA
MARCS-CMS 661617 —
June 04, 2025
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Steven Block
Recipient Title
President
Ambu USA
6721 Columbia Gateway Drive, Suite 200
Columbia
,
MD
21046
United States
stbl@ambu.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. Block:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 661617), dated August 16, 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/
Matthew G. Hillebrenner
Deputy Director
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Cc: Kleve Heavin, VP Noblesville Operations, King Systems
Content current as of:
06/16/2025
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Amy Lightner MD
MARCS-CMS 682593 —
May 06, 2025
Product:
Biologics
Recipient:
Recipient Name
Amy Lightner, MD
Amy Lightner MD
(b)(6)
United States
(b)(6)
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Secondary Issuing Offices
United States
Dear Dr. Lightner:
The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter CBER-25-682593 dated March 25, 2025. 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 from your responsibility to take all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. The Agency expects you to continuously comply with the law and will monitor your state of compliance.
Sincerely,
/S/
Melissa J. Mendoza, JD
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Content current as of:
06/03/2025
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Apitoria Pharma Private Limited Unit 1
MARCS-CMS 618091 —
November 13, 2025
Delivery Method:
Via Electronic Mail - Return Receipt Requested
Reference #:
FEI 3004021253
Product:
Drugs
Recipient:
Recipient Name
Dr. Sanjay Chaturvedi
Recipient Title
Chief Executive Officer
Apitoria Pharma Private Limited Unit 1
Floor No.’s 22, 23, & 24. Galaxy, Plot No-1, Survey no: 83/1
Knowledge City, Raidurg
Hyderabad
500032
Telangana
India
sanjay@apitoria.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Dr. Chaturvedi:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning 320-22-10 dated January 12, 2022.
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/
Daniel W. Brisker
Compliance Officer
Division of Drug Quality II
Content current as of:
11/17/2025
Regulated Product(s)
Drugs