tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Global Medical Production Co., Ltd.
MARCS-CMS 620544 —
May 14, 2026
Product:
Medical Devices
Recipient:
Recipient Name
Jeff Dai
Recipient Title
General Manager
Global Medical Production Co., Ltd.
2nd Floor, No. 4 Building, No. 3288
West ZhougShan Road
Xiuzhou Qu
Jiaxing Shi
Zhejiang Sheng
,
314031
China
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Warning Letter Close-Out
Dear Mr. Dai:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (CMS # 620544) dated November 16, 2021. Based on our evaluation, it appears that your firm has 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 yours,
/S/
For,
Anton E. Dmitriev, Ph.D.
Acting Director
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
cc: Michael Athey
mathey@orangesurgical.com
Content current as of:
05/18/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Herbal Vitality, Inc.
MARCS-CMS 640206 —
March 19, 2026
Product:
Medical Devices
Recipient:
Recipient Name
Yvan P. Rochon, PhD
Recipient Title
President
Herbal Vitality, Inc.
2810 Hopi Drive
Sedona
,
AZ
86336
United States
herbalvitality@sedona.net
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
Secondary Issuing Offices
United States
Dear Dr. Rochon:
The Food and Drug Administration has completed the evaluation of your firm’s corrective actions in response to our Warning Letter #640206, issued on March 7, 2023. Based on our evaluation, it appears the 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/
Carrie Lawlor, Branch Chief
Dietary Supplements Enforcement Branch
Office of Compliance and Enforcement
Human Foods Program
U.S. Food and Drug Administration
Content current as of:
04/07/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank
MARCS-CMS 680039 —
February 09, 2026
Delivery Method:
Via Email
Product:
Biologics
Recipient:
Recipient Name
Timothy M. Fischer
Recipient Title
President/Chief Executive Officer
Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank
4745 Haven Point Blvd.
Carmel
,
IN
46280
United States
Tfischer@visionfirst.org
Issuing Office:
Division of Biological Products Operations II
United States
Secondary Issuing Offices
United States
Dear Mr. Fischer:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter OBPO 24-680039 dated June 10, 2024. 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 Act(s) 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/
Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Content current as of:
02/12/2026
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Intuvie Holdings LLC
MARCS-CMS 629844 —
July 16, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Frederick Lee
Recipient Title
Chief Executive Officer
Intuvie Holdings LLC
Zyno Medical LLC
177 Pine St
Natick
,
MA
01760
United States
Fred.Lee@intuvie.com
Issuing Office:
Office of Medical Devices and Radiological Health Operations Div. 1 East
United States
Secondary Issuing Offices
United States
Dear Mr. Lee:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 629844, dated July 12, 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/
CAPT Cesar A. Perez, PhD, USPHS
Acting Deputy Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
07/21/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
J. D. Heiskell Holdings LLC
MARCS-CMS 700893 —
March 20, 2026
Delivery Method:
VIA EMAIL NO HARD COPY TO FOLLOW
Product:
Animal & Veterinary
Recipient:
Recipient Name
Bradley R. More
Recipient Title
Plant Manager
J. D. Heiskell Holdings LLC
2407 Warren Ave
Twin Falls
,
ID
83301-7978
United States
bmore@jdhco.com
Issuing Office:
Center for Veterinary Medicine
United States
Secondary Issuing Offices
United States
Dear Mr. More,
The United States Food and Drug Administration has completed evaluation of your facility’s corrective actions in response to our Warning Letter CMS 700893, dated June 12, 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 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/
Kelli Wilkinson
Branch Chief, Compliance Action Branch
Center for Veterinary Medicine
U.S. Food and Drug Administration
Tel: 313-393-8144
Content current as of:
03/27/2026
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Jack & The Green Sprouts, Inc.
MARCS-CMS 697257 —
January 29, 2026
Delivery Method:
Electroni Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Vincent D. Mahoney
Recipient Title
Owner
Jack & The Green Sprouts, Inc.
N8477 770th St.
River Falls
,
WI
54022
United States
eatsprouts.jgs@gmail.com
Issuing Office:
Human Foods Program
United States
Secondary Issuing Offices
United States
Dear Mr. Mahoney:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 697257, issued March 19, 2025. 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
Produce Enforcement Branch
Office of Compliance and Enforcement
The Human Foods Program
Content current as of:
01/29/2026
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Kimera Labs, Inc.
MARCS-CMS 649343 —
June 12, 2026
Delivery Method:
Via Email
Product:
Biologics
Drugs
Recipient:
Recipient Name
Duncan B. Ross, Ph.D.
Recipient Title
Chief Executive Officer
Kimera Labs, Inc.
2810 N. Commerce Parkway
Miramar
,
FL
33025-3958
United States
duncan.ross@kimeralabs.com
Issuing Office:
Division of Biological Products Operations I
United States
Secondary Issuing Offices
United States
Dear Dr. Ross:
The Food and Drug Administration (FDA) has completed evaluation of your firm's corrective actions set forth in your correspondences dated September 13, 2023, September 26, 2023, and March 19, 2024, in response to our Warning Letter dated September 01, 2023, and our response review letter dated March 07, 2024, which regarded violations relating to your Amnio2X®, XoGlo® and XoGlo®Pro products. Based on your representation that Kimera Labs has ceased the manufacture, sale, and distribution of these three products and removed them from your website and all sales channels, including through any third-party partners or affiliates, it appears that you have addressed the violations contained in this Warning Letter. FDA conducted a follow-up inspection of your firm at the above address between August 19, 2024, and August 21, 2024, and did not find evidence of continued manufacturing or distribution of the three products listed above.
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. If you have any questions regarding this letter, please contact the Division of Case Management, CBERDCMRecommendations@fda.hhs.gov.
Sincerely,
/S/
Vincent Amatrudo, JD
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
LaseTech LLC
MARCS-CMS 702493 —
April 08, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Mohamed Alamin
Recipient Title
CEO
LaseTech LLC
EpiCare Acquisitions, LLC
11 Princess Rd, Ste C
Lawrenceville
,
NJ
08648
United States
mohamed.alamin@lasetech.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. Alamin:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 702493, dated March 19, 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/
Barbara C. Marsden
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
04/14/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
LifeVac, LLC
MARCS-CMS 713455 —
March 04, 2026
Product:
Medical Devices
Ear, Nose & Throat
Recipient:
Recipient Name
Mr. Arthur Lih
Recipient Title
CEO
LifeVac, LLC
110 Lake Avenue South Ste 35
Nesconset
,
NY
11767-1071
United States
alih@lifevac.net
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
March 4, 2026
Dear Mr. Lih:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 713455, dated September 18, 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/
Srinivas Nandkumar, Ph.D.
Director,
Division of Dental and ENT Devices,
Office of Health Technology 1, Ophthalmic,
Anesthesia, Respiratory, ENT & Dental Devices
Center for Devices and Radiological Health
Content current as of:
03/04/2026
Regulated Product(s)
Medical Devices
Ear, Nose & Throat
CLOSEOUT LETTER
Livestock Nutrition Center, LLC
MARCS-CMS 698817 —
March 23, 2026
Delivery Method:
VIA EMAIL NO HARD COPY TO FOLLOW
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mr. Ben Baer
Recipient Title
Executive Chair of the Board
Livestock Nutrition Center, LLC
3680 W Jones Ave.
Garden City
,
KS
67846-9708
United States
BenBaer@LNC-ONLINE.com
Issuing Office:
Center for Veterinary Medicine
United States
Secondary Issuing Offices
United States
Dear Mr. Baer,
The United States Food and Drug Administration has completed evaluation of your facility’s corrective actions in response to our Warning Letter CMS# 698817, dated April 11, 2025. Your facility’s 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/
Kelli Wilkinson
Branch Director, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
Tel: 313-393-8144
cc: Lon (Sam) E. Huntley, Location Facility Manager
Livestock Nutrition Center, LLC
3680 W. Jones Ave.
Garden City, KS
Sam.Huntely@LNC-ONLINE.com
Content current as of:
03/27/2026
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Lone Pine Farm
MARCS-CMS 654161 —
March 02, 2026
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Elmer Beechy
Recipient Title
Owner
Lone Pine Farm
25251 Hwy O
Flemington
,
MO
65650-8211
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
Secondary Issuing Offices
United States
Dear Mr. Beechy:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #654161, issued June 26, 2023. Based on our evaluation of our inspection conducted July 30, 2025, 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/
Victoria Wagoner, Acting Branch Chief
Conventional Foods Enforcement Branch 1
Division of Conventional Foods Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
03/17/2026
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Marli Washington Design, LLC
MARCS-CMS 720840 —
March 27, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Marli Washington
Recipient Title
Manager
Marli Washington Design, LLC
2502 Harford Rd
Baltimore
,
MD
21218
United States
legal@gc2b.info
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Marli Washington:
The Food and Drug Administration (FDA) has completed an evaluation of Marli Washington Design, LLC d/b/a gc2b corrective actions in response to our Warning Letter CMS #720840, dated December 16th, 2025. 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
Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Marli Washington
Marli Washington Design, LLC d/b/a gc2b
cc: Shopify, Inc.
abuse@shopify.com
abuse@gc2b.co; support@gc2b.co
Content current as of:
04/02/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
MD Pharmaceutical Supply, LLC
MARCS-CMS 637815 —
April 13, 2026
Delivery Method:
Via Email
Reference #:
FEI 3012369470
Product:
Drugs
Recipient:
Recipient Name
Mr. Richard J. Romeo
Recipient Title
President and Owner
MD Pharmaceutical Supply, LLC
P.O. Box 244
Hanover
,
PA
17331
United States
rromeo@mdpharmaceutical.com
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Secondary Issuing Offices
United States
Dear Mr. Romeo:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (Case # 637815) dated November 22, 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/
Christina Alemu-Cruickshank
Compliance Officer
Division of Drug Quality I
Content current as of:
04/17/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
MedisourceRx
MARCS-CMS 717970 —
July 27, 2026
Delivery Method:
VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT
Product:
Drugs
Recipient:
Recipient Name
Daniel D. Hernandez
Recipient Title
Director of Quality
MedisourceRx
10525 Humbolt Street
Los Alamitos
,
CA
90720-5401
United States
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Hernandez:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #717970, issued on December 12, 2025. 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:
07/30/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Nephron SC, LLC
MARCS-CMS 634647 —
May 08, 2026
Reference #:
FEI 3010892830
Product:
Drugs
Recipient:
Recipient Name
Ms. Lou W. Kennedy
Recipient Title
Chief Executive Officer
Nephron SC, LLC
4500 12th Street Ext.
West Columbia
,
SC
29172
United States
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
Secondary Issuing Offices
United States
Dear Ms. Kennedy:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Case # 634647 dated October 11, 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/
Michael Klapal
Consumer Safety Officer
Office of Manufacturing Quality
Content current as of:
05/18/2026
Regulated Product(s)
Drugs