tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Yeshua Bendito, C.A.
MARCS-CMS 693457 —
June 09, 2025
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Willy Ocando
Recipient Title
General Manager
Yeshua Bendito, C.A.
Av 2 Nro 23-79 Barrio San Luis
San Francisco
4004
,
Zulia
Venezuela
yesbenca@hotmail.com
Issuing Office:
Human Foods Program
United States
Secondary Issuing Offices
United States
Dear Mr. Ocando:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, CMS# 693457 dated November 1, 2024. 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/
Robyn R. Jones, Branch Chief
Conventional Foods Enforcement Branch 2
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
06/23/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Zhejiang Tianyu Pharmaceutical Co Ltd
MARCS-CMS 631054 —
February 28, 2025
Reference #:
FEI 3010972581
Product:
Drugs
Recipient:
Recipient Name
Mr. Tu Yongjun
Recipient Title
President and Founder
Zhejiang Tianyu Pharmaceutical Co Ltd
Jiangkou Development Zone
Huangyan Qu
Taizhou Shi
Zhejiang Sheng
,
318020
China
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Youngjun:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-22-23 dated August 17, 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/
Sai S. Dharmaraj
Compliance Officer
Division of Drug Quality I
Content current as of:
03/11/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Zoet Poultry, Inc.
MARCS-CMS 668611 —
June 26, 2025
Product:
Food & Beverages
Recipient:
Recipient Name
Timothy R. Zweering
Recipient Title
President
Zoet Poultry, Inc.
4847 140th Ave
Holland
,
MI
49423-9546
United States
tzweering@zoetpoultry.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Secondary Issuing Offices
United States
Dear Mr. Timothy R. Zweering:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #668611, 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, Branch Chief
Conventional Foods Enforcement Branch 2
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
07/15/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Zydus Lifesciences Limited
MARCS-CMS 685224 —
December 09, 2025
Reference #:
FEI 3013712903
Product:
Drugs
Recipient:
Recipient Name
Dr. Sharvil Patel
Recipient Title
Managing Director
Zydus Lifesciences Limited
Zydus Corporate Park, S.G. Highway
Nr. Vashnodevi Circle
Ahmedabad
382482
India
Issuing Office:
United States
Secondary Issuing Offices
United States
Dear Mr. Patel:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-24-58 dated August 29, 2024.
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/
Kevin Maguire
Consumer Safety Officer
Division of Drug Quality III
Content current as of:
12/16/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
4U Health
MARCS-CMS 720527 —
June 16, 2026
Delivery Method:
Via Email
Product:
Biologics
Drugs
Recipient:
Recipient Name
Alfred Caminos
Recipient Title
Co-Founder and Managing Director
4U Health
71 Lighthouse Road, Suite 220
Hilton Head Island
,
SC
29928
United States
help@4uhealth.com
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Secondary Issuing Offices
United States
Dear Alfred Caminos:
The Food and Drug Administration (FDA) has completed evaluation of your firm's corrective actions in response to our Warning Letter dated March 17, 2026, set forth in your correspondence dated April 23, 2026. Based on your representation that 4U Health “has discontinued direct-to-consumer marketing on 4uhealth.com of professional HIV medical screening services, pertaining to the physician ordering and medical oversight of self-collected dried blood spot specimens”, it appears that you have addressed the violation(s) contained in this Warning Letter.
While we acknowledge that you no longer offer HIV DBS card self-collection kits for sale on your website, we note that your website still states “HIV” under the “Shop Our Tests” drop-down menu within the “STD/STI tests” section. As it appears based on your representations noted above you have discontinued marketing tests for HIV and do not intend to resume doing so, please remove references to HIV tests from your website and confirm completion of this action within 15 business days of receipt of this letter. Future FDA surveillance 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, please contact the Division of Case Management, CBERDCMRecommendations@fda.hhs.gov.
Sincerely,
/S/
Vincent Amatrudo
Acting Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Content current as of:
06/23/2026
Regulated Product(s)
Biologics
Drugs
CLOSEOUT LETTER
5000 Years Foods, Inc.
MARCS-CMS 617797 —
January 09, 2026
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Sang C. Hong
Recipient Title
Owner
5000 Years Foods, Inc.
984 Lee Street
Des Plaines
,
IL
60016-6513
United States
5000YearsFoods@gmail.com
Issuing Office:
Office of Human and Animal Food Operations, East Division VI
United States
Secondary Issuing Offices
United States
Dear Mr. Hong:
The Food and Drug Administration has completed evaluation of your corrective actions in response to FDA Warning Letter #617797, issued on January 27, 2022, during an inspection of your facility conducted on November 6 through 26, 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 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/
Clarice J. Ahn, Acting Branch Chief
Division of Conventional Foods Enforcement
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
01/23/2026
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Adnan M. Dahdul, M.D.
MARCS-CMS 719607 —
May 15, 2026
Product:
Biologics
Recipient:
Recipient Name
Adnan Dahdul, MD
Adnan M. Dahdul, M.D.
95 Frank B Murray Street
Springfield
,
MA
01103
United States
adahdul@sisuhealth.com
Issuing Office:
Office of Compliance and Biologics Quality
United States
Secondary Issuing Offices
United States
Dear Dr. Dahdul:
The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter CBER-26-719607 dated March 11, 2026. 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/
Carrie M. Mampilly, MPH
Director, Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
CC:
Mishelle Harriger, SCSO, OII, OBMI Division 1
OIIBIMODivision1Correspondence@fda.hhs.gov
Content current as of:
05/28/2026
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Advanced Nutriceuticals LLC dba The Guyer Institute of Molecular Medicine
MARCS-CMS 615908 —
February 24, 2026
Delivery Method:
Via Electronic Mail - Delivery and Read Receipt Requested
Product:
Drugs
Recipient:
Recipient Name
Leonard D. Guyer, MD
Recipient Title
Owner and President
Advanced Nutriceuticals LLC dba The Guyer Institute of Molecular Medicine
836 E. 86th Street
Indianapolis
,
IN
46240-1806
United States
Issuing Office:
Division of Pharmaceutical Quality Operations Division III
United States
Secondary Issuing Offices
United States
Dear Dr. Guyer:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter, WL#615908, issued on November 10, 2021. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and 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.
Sincerely,
/S/
Matthew J. Lash
Acting Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
03/17/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Azurity Pharmaceuticals, Inc.
MARCS-CMS 656489 —
February 24, 2026
Reference #:
FEI 3003395329
Product:
Drugs
Recipient:
Recipient Name
Mr. Ronald Scarboro
Recipient Title
CEO
Azurity Pharmaceuticals, Inc.
900 Ridgefield Drive
Raleigh
,
NC
27609
United States
rscarboro@azurity.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Scarboro:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (656489) dated September 20, 2024.
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/
Carmelo Rosa, Psy.D.
Director, Division of Drug Quality I
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
CC:
Ms. Marie Romanow
Director of Quality Compliance
Azurity Pharmaceuticals, Inc.
8 Cabot Road, Suite 2000
Woburn, MA 01801
marie.romanow@azurity.com
Content current as of:
03/03/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Bell International Laboratories, Inc.
MARCS-CMS 669736 —
March 04, 2026
Reference #:
FEI 3005574978
Product:
Drugs
Recipient:
Recipient Name
Mr. Paul Eichholz
Recipient Title
Vice President of Quality & Regulatory Compliance
Bell International Laboratories, Inc.
2950 Lexington Ave S., Suite 100
Eagan
,
MN
55121
United States
p.eichholz@bellintlabs.com
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
Secondary Issuing Offices
United States
Dear Mr. Eichholz:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Case #669736 dated February 15, 2024.
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:
03/12/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
BioXtek LLC
MARCS-CMS 715478 —
February 11, 2026
Delivery Method:
Via Email
Product:
Biologics
Medical Devices
Recipient:
Recipient Name
Bruce R. Werber, DPM
Recipient Title
Chief Executive Officer and Founder
BioXtek LLC
316 NE 1st St
Pompano Beach
,
FL
33060
United States
docw@bioxtek.com
Issuing Office:
Office of Compliance and Biologics Quality
United States
Secondary Issuing Offices
United States
Dear Dr. Werber:
The Food and Drug Administration (FDA) has completed its evaluation of your firm's corrective actions in response to our Warning Letter dated December 1, 2025, as detailed in your correspondence dated December 11, 2025. Based on your removal of the video containing the cited claims from your website and your representation that the video has been removed from other public platforms, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will 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 questions regarding this letter, contact the Division of Case Management, CBER at (240) 402-9156 or email CBERDCMRecommendations@fda.hhs.gov.
Sincerely,
/S/
Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Content current as of:
02/19/2026
Regulated Product(s)
Biologics
Medical Devices
CLOSEOUT LETTER
Compass Group USA
MARCS-CMS 709592 —
April 22, 2026
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Tim Lonc
Recipient Title
President
Compass Group USA
Fresh & Ready Foods LLC
2400 Yorkmont Road
Charlotte
,
NC
28217
United States
Tim.lonc@compass-usa.com
Issuing Office:
Human Foods Program
United States
Secondary Issuing Offices
United States
Dear Mr. Lonc:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 709592, issued September 5, 2025. We currently have no further comments. We will verify the effectiveness of your correction during our next inspection of your operations.
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/
Crystal McKenna, Ph.D.
Acting Branch Chief
Emerging Issues Branch
Office of Compliance and Enforcement
The Human Foods Program
Content current as of:
04/28/2026
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
CSL Behring
MARCS-CMS 716297 —
May 13, 2026
Reference #:
BLA 125350/1472
Product:
Biologics
Recipient:
Recipient Name
Pamela Lee
Recipient Title
Head, Global Advertising & Promotion
CSL Behring
1060 First Avenue
King of Prussia
,
PA
19406
United States
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Secondary Issuing Offices
United States
Dear Ms. Lee:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter dated September 09, 2025. 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 during subsequent surveillance or through other means.
Sincerely,
/S/
Kristine Khuc, Pharm.D.
Branch Chief
Advertising and Promotional Labeling Branch
Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Content current as of:
05/21/2026
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
MARCS-CMS 614402 —
June 05, 2026
Reference #:
FEI 3010166780
Product:
Drugs
Recipient:
Recipient Name
Ms.Gulten Erdemir
Recipient Title
General Manager
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
Bolgesi Aydinli Sb Mahallesi
6 12 Istanbul Endustri Veticaret Serbest
34953
Sokak Tuzla
/
İstanbul
Turkey
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Ms. Erdemir:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-11 dated February 13, 2023, and Warning Letter 320-21-51 dated July 8, 2021.
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/
Bryce Hammer
Compliance Officer
Division of Drug Quality II
Content current as of:
06/09/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
MARCS-CMS 645478 —
June 05, 2026
Reference #:
FEI 3010166780
Product:
Drugs
Recipient:
Recipient Name
Ms. Gulten Erdemir
Recipient Title
General Manager
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
Bolgesi Aydinli Sb Mahallesi
6 12 Istanbul Endustri Veticaret Serbest
34953
Sokak Tuzla
/
İstanbul
Turkey
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Ms. Erdemir:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-11 dated February 13, 2023, and Warning Letter 320-21-51 dated July 8, 2021.
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/
Bryce Hammer
Compliance Officer
Division of Drug Quality II
Content current as of:
06/09/2026
Regulated Product(s)
Drugs