tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Dollar Tree Inc.
MARCS-CMS 629509 —
May 18, 2026
Delivery Method:
Via Email with Confirmation of Receipt
Product:
Food & Beverages
Recipient:
Recipient Name
Michael C. Creedon Jr.
Recipient Title
Chief Executive Officer
Dollar Tree Inc.
500 Volvo Parkway
Chesapeake
,
VA
23320
United States
Issuing Office:
Office of Human and Animal Food Operations – West Division 3
United States
Secondary Issuing Offices
United States
Dear Mr. Creedon:
The United States Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 629509, issued November 8, 2022. 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/
Victoria Wagoner
Acting Branch Chief
Human Foods Program
Office of Compliance and Enforcement
Office of Enforcement
Division of Conventional Foods Enforcement
Content current as of:
05/21/2026
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Dr. Joel Kaplan, Inc.
MARCS-CMS 667193 —
February 25, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Shumuel Itshaki
Recipient Title
Chief Executive Officer
Dr. Joel Kaplan, Inc.
3550 Market St, Ste. B
San Diego
,
CA
92102-3348
United States
sam@drjoelkaplan.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. Itshaki:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 667193, dated January 8, 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 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
Acting Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
03/03/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
DuPont Nutrition USA Inc.
MARCS-CMS 627211 —
July 22, 2026
Reference #:
FEI 3013947845
Product:
Drugs
Recipient:
Recipient Name
Mr. Shoba Reddy Chagam
Recipient Title
Head of Global Regulatory Affairs & Head of Regulatory Affairs Americas
DuPont Nutrition USA Inc.
Roquette Health and Pharma Solutions BG
1301 Ogletown Road
Newark
,
DE
19711-5419
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Secondary Issuing Offices
United States
Dear Mr. Chagam:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #627211, dated December 2, 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/
LaKeesha M. Sifontes
Group Supervisor
Division of Drug Quality II
Content current as of:
07/30/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Early to Bed, Inc.
MARCS-CMS 720822 —
March 27, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Searah Deysach
Recipient Title
President
Early to Bed, Inc.
5138 North Clark Street
Chicago
,
IL
60640
United States
searah@early2bed.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Searah Deysach:
The Food and Drug Administration (FDA) has completed an evaluation of Early to Bed, Inc. corrective actions in response to our Warning Letter CMS #720822, 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
Xander Shephard
GenderBender LLC
cc: Shopify, Inc. abuse@shopify.com
cc: gbllcservices@gmail.com
Content current as of:
03/31/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Eden F&C, Co., Ltd.
MARCS-CMS 694712 —
February 04, 2026
Product:
Food & Beverages
Recipient:
Recipient Name
Jinmin Kim
Recipient Title
CEO
Eden F&C, Co., Ltd.
6381 Nambu-Ro
Naebung-Myeon
Boeun-gun
Chungcheongbuk-do
28900
South Korea
whsuk1@daum.net
Issuing Office:
Human Foods Program
United States
Secondary Issuing Offices
United States
Dear Mr. Kim:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS # 694712, issued on November 6, 2024, for your facility located at 6381 Nambu-Ro, Naebung-Myeon, Boeun, Chungcheongbuk, Korea (the Republic of) 28900. 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/
Victoria Wagoner
Acting Branch Chief, Conventional Foods Enforcement Branch 1
Office of Enforcement
Office of Compliance & Enforcement
Human Foods Program
Content current as of:
02/19/2026
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Edge Biologicals Inc
MARCS-CMS 660003 —
February 23, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Walter C. Edge III
Recipient Title
Vice President
Edge Biologicals Inc
598 N 2nd Street
Memphis
,
TN
38105-1634
United States
cal@edgebiological.com
Issuing Office:
Division of Medical Device and Radiological Health Operations Central
United States
Secondary Issuing Offices
United States
Dear Mr. Edge:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 660003, dated June 27, 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/
Barbara C. Marsden
Acting Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
03/03/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Elanco Animal Health USA
MARCS-CMS 710613 —
August 05, 2026
Reference #:
NADA 141-550, Pradalex™ pradofloxacin injection
Product:
Animal & Veterinary
Recipient:
Recipient Name
Jeffrey Simmons
Recipient Title
President and CEO
Elanco Animal Health USA
2500 Innovation Way
Greenfield
,
IN
46140
United States
Issuing Office:
Center for Veterinary Medicine
United States
Secondary Issuing Offices
United States
Dear: Mr. Simmons
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated, January 8, 2026. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter. Future FDA surveillance 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 U.S. 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.
If you have any questions or comments, please contact Dr. Christopher Loss at christopher.loss@fda.hhs.gov. If you wish to send a response, please send by email to CVMSurveillance@fda.hhs.gov. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter #710613.
Sincerely,
/S/
Linda Walter-Grimm, DVM
Director, Division of Pharmacovigilance and Surveillance
Office Surveillance and Compliance
Center for Veterinary Medicine
Content current as of:
08/06/2026
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Eurosirel S.P.A
MARCS-CMS 690733 —
January 26, 2026
Delivery Method:
Via Electronic Mail - Return Receipt Requested
Reference #:
FEI 3015892095
Product:
Drugs
Recipient:
Recipient Name
Mr. Matteo Scarpis
Recipient Title
CEO
Eurosirel S.P.A
Viale Europa 30
20047
Cusago
MI
Italy
matteo.scarpis@eurosirel.it
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Scarpis:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-25-17 dated November 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/
Daniel W. Brisker
Compliance Officer
Division of Drug Quality II
Content current as of:
02/02/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
FLAVNT Streetwear, LLC
MARCS-CMS 720838 —
March 27, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Christopher Rhodes
Recipient Title
Manager
FLAVNT Streetwear, LLC
6303 Virgo Ln
Austin
,
TX
78724-4322
United States
abuse@flavnt.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Christopher Rhodes:
The Food and Drug Administration (FDA) has completed an evaluation of FLAVNT Streetwear, LLC corrective actions in response to our Warning Letter CMS #720838, 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
Christopher Rhodes
FLAVNT Streetwear, LLC
cc: Shopify, Inc. abuse@shopify.com
cc: yourpals@flavnt.com
Content current as of:
03/31/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Flux Lab Pte. Ltd. d/b/a The Fluxion
MARCS-CMS 720847 —
March 27, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Yan Nie
Recipient Title
Director
Flux Lab Pte. Ltd. d/b/a The Fluxion
60 Paya Lebar Road #12-03
Paya Lebar Square
409051
Singapore
support@thefluxion.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Yan Nie:
The Food and Drug Administration (FDA) has completed an evaluation of Flux Lab Pte. Ltd. d/b/a The Fluxion corrective actions in response to our Warning Letter CMS #720847, 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
Content current as of:
04/07/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Furst-McNess Company
MARCS-CMS 668925 —
April 30, 2026
Delivery Method:
VIA EMAIL NO HARD COPY TO FOLLOW
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mark Poeschl
Recipient Title
CEO
Furst-McNess Company
1252 Bell Valley Road, Suite 220
Rockford
,
IL
61108
United States
jeff.davidson@mcness.com
Issuing Office:
Division of Human and Animal Food Operations West I
United States
Secondary Issuing Offices
United States
Dear Mark Poeschl,
The United States Food and Drug Administration has completed evaluation of your facility’s corrective actions in response to our Warning Letter CMS 668925, dated March 12, 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/
CDR Kelli Wilkinson
Branch Director, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
Content current as of:
05/04/2026
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
GenderBender LLC
MARCS-CMS 720842 —
March 27, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Xander Shephard
Recipient Title
Manager
GenderBender LLC
21042 S Main St
Carson
,
CA
90724
United States
genderbenderapparel@gmail.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Xander Shephard:
The Food and Drug Administration (FDA) has completed an evaluation of GenderBender LLC corrective actions in response to our Warning Letter CMS #720842, 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
Xander Shephard
GenderBender LLC
cc: Shopify, Inc. abuse@shopify.com
cc: gbllcservices@gmail.com
Content current as of:
04/02/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Germaphobix
MARCS-CMS 720555 —
February 10, 2026
Delivery Method:
Via Email
Product:
Biologics
Recipient:
Recipient Name
Jon Tavarez
Recipient Title
Founder & Chief Executive Officer
Germaphobix
6950 E Adamo Dr
Tampa
,
FL
33619
United States
info@germaphobix.com
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Secondary Issuing Offices
United States
Dear Jon Tavarez:
The Food and Drug Administration (FDA) has completed evaluation of your firm's corrective actions in response to our Warning Letter dated January 09, 2026, set forth in your correspondence dated January 20, 2026. Based on your representation that Germaphobix has removed all products, references, and content related to any HIV testing (including any at-home HIV tests, STD panels that include HIV, or similar self-collection kits) from your website and all sales channels, including through any third-party partners or affiliates, and will refrain in the future from offering or distributing any diagnostic devices or self-collection kits for serological testing without first obtaining required FDA marketing authorization, it appears that you have addressed the violation(s) contained in this Warning 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 an 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/
Melissa J. Mendoza, JD
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Content current as of:
02/19/2026
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Global Calcium House 1
MARCS-CMS 692000 —
July 30, 2026
Reference #:
FEI 3004094136
Product:
Drugs
Recipient:
Recipient Name
Mr. Sahil Vaz
Recipient Title
Chief Executive Officer (CEO)/ Managing Director
Global Calcium House 1
Global Calcium Pvt. Limited
Hundred Feet Road
Koramangala Bangalore
560095
India
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Vaz:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-25-30 dated January 16, 2025.
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/
Matthew Jensen
Compliance Officer
Division of Drug Quality I
Content current as of:
07/30/2026
Regulated Product(s)
Drugs