tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Konrad Rejdak, MD, PhD
MARCS-CMS 671405 —
May 01, 2025
Product:
Drugs
Recipient:
Recipient Name
Konrad Rejdak, M.D.
Konrad Rejdak, MD, PhD
Samodzielny Publiczny Szpital
Kliniczny Nr 4 w Lublinie, ul. Jaczewskiego 8,
20-090
Lublin
Poland
Rejdakk@gmail.com
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Secondary Issuing Offices
United States
Dear Dr. Rejdak:
The United States Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CBER 24-671405 dated May 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.
The FDA conducted this assessment under the Bioresearch Monitoring (BIMO) Program that includes inspections designed to review the conduct of research involving investigational products.
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 other applicable law.
The FDA has several references available at www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm that offer information on human subject protection and the conduct of clinical research. If you have any questions, you may contact CDR Peter Lenahan by email at Peter.Lenahan@FDA.HHS.GOV.
Sincerely,
/S/
Melissa J. Mendoza, JD
Director, Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
cc:
Baxalta US Inc.
300 Shire Way
Lexington, MA 02421
Jennifer Adams, Branch Chief
FDA OII BIMO Foreign Investigation Branch
Content current as of:
11/10/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Kuzmir Imports Inc.
MARCS-CMS 633082 —
April 29, 2025
Product:
Food & Beverages
Recipient:
Recipient Name
Yehuda Loeffler
Recipient Title
President
Kuzmir Imports Inc.
201 Route 59, Building A1
Hillburn
,
NY
10931
United States
Issuing Office:
Division of Northeast Imports
United States
Secondary Issuing Offices
United States
Dear Mr. Loeffler:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 633082 dated August 02, 2022. Based on our evaluation, it appears that 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/
Anna Alexander
Director, Compliance Branch
Division of Northeast Imports
U.S. Food and Drug Administration
Content current as of:
05/08/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
LEC Custom Products, Inc.
MARCS-CMS 607838 —
June 18, 2025
Reference #:
FEI 3004737602
Product:
Drugs
Recipient:
Recipient Name
Mr. Jeremy Willard
Recipient Title
President & CEO
LEC Custom Products, Inc.
7 Kenview Boulevard
Brampton
ON
L6T 5G5
Canada
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Willard:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s remediation in response to our Warning Letter 320-20-47 dated September 24, 2020. Based on our evaluation, it appears that you have addressed the matter by no longer manufacturing drugs.
While the available information indicates that you no longer manufacture human drugs, your corrective actions do not involve coming into compliance with Current Good Manufacturing Practice (CGMP) requirements by manufacturing human drugs in accordance with CGMP requirements. Therefore, FDA has not had the opportunity to verify, via onsite inspection, CGMP compliance. While we consider this matter closed, note that if and when you resume the manufacturing of human drugs in the future, any human drugs you manufacture will be subject to the requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and failure to manufacture human drugs in accordance with CGMP requirements would cause those drugs to be adulterated.
Adulterated drugs are subject to refusal of admission into the United States under section 801(a)(3) of the FD&C Act. In addition, the receipt in interstate commerce of adulterated drugs and delivery or proffered delivery thereof for pay or otherwise is a violation of section 301(c) of the FD&C Act.
In addition, all applicable requirements of the FD&C Act would apply to any human drugs you manufacture in the future. Also, if you resume drug manufacturing activities, you will be required to register with FDA as a drug establishment. Notify us if this occurs.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the FD&C 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 compliance status. This letter will not preclude any future regulatory action if violations are observed during a subsequent inspection or through other means.
If you have any questions regarding this letter, contact CDER-OC-OMQ-Communications@fda.hhs.gov ATTN: Kevin Maguire
Sincerely,
/s/
Milind Ganjawala
Acting Director
Division of Drug Quality III
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
06/26/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Maribel's Sweets, Inc.
MARCS-CMS 616288 —
March 11, 2025
Product:
Food & Beverages
Recipient:
Recipient Name
Maribel Lieberman
Recipient Title
CEO
Maribel's Sweets, Inc.
38 Dobbin St.
2nd Floor
Brooklyn
,
NY
11222
United States
mariebellechocolat@icloud.com
Issuing Office:
Office of Human and Animal Food Operations - East Division 1
United States
Secondary Issuing Offices
United States
Dear Ms. Lieberman:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS 616288 and dated October 25, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Lisa Thursam, Acting Branch Chief
Division of Conventional Foods Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
03/20/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Mariscos Procesados CAMPRESA S.A.
MARCS-CMS 694846 —
February 18, 2025
Delivery Method:
Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Yen Yi Chen
Recipient Title
President
Mariscos Procesados CAMPRESA S.A.
KM 106.5 Carretera Panamericana
Rivas
Nicaragua
Toreros19812004@gmail.com
Campresa888@gmail.com
Issuing Office:
Human Foods Program
United States
Secondary Issuing Offices
United States
Dear Mr. Chen:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 694846, issued November 5, 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:
03/04/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Massachusetts Institute of Technology MIT
MARCS-CMS 663218 —
January 28, 2025
Product:
Biologics
Recipient:
Recipient Name
Dr. Leigh M. Firn MD
Massachusetts Institute of Technology MIT
Committee on the Use of Humans as Experimental Subjects (COUHES)
77 Massachusetts Avenue, Building E25, Room 143B
Cambridge
,
MA
02139-4301
United States
lfirn@mit.edu
Issuing Office:
Center for Biologics Evaluation and Research
United States
Secondary Issuing Offices
United States
Dear Dr. Firn:
The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter CBER-24-663218 dated June 21, 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 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 and your firm 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:
02/12/2025
Regulated Product(s)
Biologics
CLOSEOUT LETTER
McClure's Lancaster Old Fashioned, LLC
MARCS-CMS 670611 —
July 21, 2025
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Thomas Keenan
Recipient Title
Owner & President
McClure's Lancaster Old Fashioned, LLC
1212 Reading Road
Bowmansville
,
PA
17507
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Secondary Issuing Offices
United States
Dear Mr. Keenan:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (#670611) on May 16, 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:
07/28/2025
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Medgel Private Limited
MARCS-CMS 654085 —
May 22, 2025
Delivery Method:
Via Electronic Mail - Delivery and Read Receipt Requested
Reference #:
FEI 3010165392
Product:
Drugs
Recipient:
Recipient Name
Mr. Alok K. Garg
Recipient Title
Managing Director
Medgel Private Limited
Plot No. 19-20, Special Economic Zone
Pharma Zone, Phase-II, Sector-III
Pithampur
454775
Madhya Pradesh
India
akg@medgel.net
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Garg:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-17 dated July 20, 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/
William Yang
Compliance Officer
Division of Drug Quality II
Content current as of:
05/29/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
MicroVention Costa Rica S.R.L.
MARCS-CMS 643188 —
September 16, 2025
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Alberto Meseguer
Recipient Title
Vice President and General Manager
MicroVention Costa Rica S.R.L.
Coyol Free Zone, Building B33
Alajuela
20101
Costa Rica
Alberto.Meseguer@microvention.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. Meseguer:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 643188, dated September 30, 2022). 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/
for Bram Zuckerman, M.D.
Director
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Scafford Serron
35 Enterprise
Aliso Viejo, CA 92656
Scafford.Serron@microvention.com
Content current as of:
11/17/2025
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Mid America Pet Food, LLC
MARCS-CMS 681516 —
August 21, 2025
Delivery Method:
VIA EMAIL WITH READ RECEIPT: NO HARD COPY TO FOLLOW
Product:
Animal & Veterinary
Food & Beverages
Recipient:
Recipient Name
Jeff Caswell
Recipient Title
Chief Executive Officer
Mid America Pet Food, LLC
2024 N. Frontage Road
Mount Pleasant
,
TX
75455-6474
United States
mfrederking@MAPF.com
Issuing Office:
Center for Veterinary Medicine
United States
Secondary Issuing Offices
United States
Dear Jeff Caswell,
The United States Food and Drug Administration has completed evaluation of your facility’s corrective actions in response to our Warning Letter CMS 681516, dated November 22, 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 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/
Andrew Howard
For
Kelli Wilkinson
Branch Director, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
Content current as of:
08/28/2025
Regulated Product(s)
Animal & Veterinary
Food & Beverages
CLOSEOUT LETTER
Namita A. Goyal, M.D.
MARCS-CMS 677324 —
February 04, 2025
Product:
Biologics
Recipient:
Recipient Name
Namita A. Goyal, MD
Namita A. Goyal, M.D.
UC Irvine Health
200 S. Manchester Ave, Suite 110
Orange
,
CA
92868-3214
United States
namitag@hs.uci.edu
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Secondary Issuing Offices
United States
Dear Dr. Goyal:
The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter CBER-24-677324 dated October 10, 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 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 and your firm 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:
02/19/2025
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Natco Pharma Limited
MARCS-CMS 672564 —
September 25, 2025
Product:
Drugs
Recipient:
Recipient Name
Mr. Sandeep Kumar
Recipient Title
Vice President - Quality
Natco Pharma Limited
Pharma Division, Kothur Village
Rangareddy
509228
Telangana
India
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Kumar:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-24-32 dated August 8, 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/
Rafael Arroyo
Compliance Officer
Division of Drug Quality I
Content current as of:
09/29/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Natuzen Co., Ltd.
MARCS-CMS 677942 —
March 03, 2025
Reference #:
FEI 3006731547
Product:
Drugs
Recipient:
Recipient Name
Mr. Young-Gi Son
Recipient Title
President
Natuzen Co., Ltd.
289 Namdongdong-Ro
Namdong-gu
Incheon
21639
South Korea
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Son:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-24-36 dated May 3, 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/
Joel Hustedt
Compliance Officer
Division of Drug Quality II
Content current as of:
03/11/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Nikkiso Co, Ltd.
MARCS-CMS 613109 —
July 23, 2025
Product:
Medical Devices
Recipient:
Recipient Name
Koichi Kato
Recipient Title
Representative Director, President & Chief Executive Officer
Nikkiso Co, Ltd.
20-3, Ebisu 4-Chome, Shibuya-ku
Tokyo
150-6022
Japan
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Koichi Kato:
The Food and Drug Administration has completed an evaluation of Nikkiso’s corrective actions in response to our Warning Letter (CMS #613109; dated May 7th, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Michael J. Hoffmann
Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration
Content current as of:
07/29/2025
Regulated Product(s)
Medical Devices