tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Outset Medical, Inc.
MARCS-CMS 656485 —
February 13, 2025
Product:
Medical Devices
Recipient:
Recipient Name
Leslie Trigg
Recipient Title
Chair and CEO
Outset Medical, Inc.
3052 Orchard Drive
San Jose
,
CA
95134-2011
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Ms. Trigg:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 656485, dated 7/5/2023. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
for RDML Sean M. Boyd, MPH, USPHS
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
02/19/2025
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC
MARCS-CMS 654751 —
May 19, 2025
Delivery Method:
Via Email
Reference #:
2851, CMS 654751
Product:
Drugs
Recipient:
Recipient Name
Kunjal Joshi
Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC
2004 Orville Drive North
Ronkonkoma
,
NY
11779
United States
kunjal@prodosepharma.com
kunjal@spiritpharma.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Kunjal Joshi:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2851, CMS 654751. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. 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/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Content current as of:
05/22/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
ReConserve of Maryland, Inc.
MARCS-CMS 663413 —
April 11, 2025
Delivery Method:
VIA EMAIL WITH READ RECEIPT: NO HARD COPY TO FOLLOW
Product:
Food & Beverages
Recipient:
Recipient Name
Keith Rudd
Recipient Title
Vice President, Environmental Health & Safety
ReConserve of Maryland, Inc.
3220 Sun Street
Baltimore
,
MD
21226-1050
United States
krudd@reconserve.com
Issuing Office:
Division of Human and Animal Food Operations East II
United States
April 11, 2025
Dear Keith Rudd,
The United States Food and Drug Administration has completed evaluation of your facility’s corrective actions in response to our Warning Letter CMS 663413, dated January 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 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/
Justin N. Henson
Branch Chief, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
U.S. Department of Health and Human Services
Content current as of:
04/14/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
The Royal Ice Cream Company Inc.
MARCS-CMS 630433 —
April 07, 2025
Product:
Food & Beverages
Recipient:
Recipient Name
James S Orfitelli
Recipient Title
President
The Royal Ice Cream Company Inc.
27 Warren St
Manchester
,
CT
06040-6534
United States
Issuing Office:
Human Foods Program
United States
DATE: April 7, 2025
CMS Case: 630433
Dear Mr. Orfitelli:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 630433) on July 28, 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 correction
s.
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:
04/10/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Safe Chain Solutions, LLC
MARCS-CMS 636044 —
March 10, 2025
Reference #:
FEI 3009728473
Product:
Drugs
Recipient:
Recipient Name
Amanda Biggart and Dakota Flowers
Recipient Title
Chief Operating Officer/Compliance Manager
Safe Chain Solutions, LLC
822 Chesapeake Dr
Cambridge
,
MD
21613-9408
United States
855-437-5727
AmandaB@SafeChain.com
DakotaF@SafeChain.com
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Secondary Issuing Offices
United States
Dear Ms. Biggart and Ms. Flowers,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 636044, dated June 8, 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/
Tia Harper-Velazquez, Director
Division of Supply Chain Integrity
Office of Drug Security, Integrity and Response
Office of Compliance
Center for Drug Evaluation and Research U.S. Food & Drug Administration
Content current as of:
03/17/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Safecor Health, LLC
MARCS-CMS 657886 —
January 17, 2025
Product:
Drugs
Recipient:
Recipient Name
Mr. Stephen T. Fischbach
Recipient Title
President and Chief Executive Officer
Safecor Health, LLC
4060 Business Park Drive
Columbus
,
OH
43204
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Secondary Issuing Offices
United States
Dear Mr. Fischbach:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 657886 dated September 5, 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/
Jamie Dion
Compliance Officer
Division of Drug Quality II
Content current as of:
02/10/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Signature Biologics, LLC
MARCS-CMS 631039 —
February 21, 2025
Delivery Method:
Via Email
Product:
Biologics
Recipient:
Recipient Name
Neil H. Riordan, Ph.D.
Recipient Title
Chief Executive Officer
Signature Biologics, LLC
4040 W. Royal Lane, Suite 100
Irving
,
TX
75063-2844
United States
neil@aidanresearch.com
Issuing Office:
Division of Biological Products Operations II
United States
Secondary Issuing Offices
United States
Dear Dr. Neil H. Riordan:
The United States Food and Drug Administration (FDA) has reviewed your firm’s corrective actions in response to Warning Letter #OBPO 23-631039 issued to you on September 18, 2023. Based on our evaluation of your response, your cessation of manufacture and distribution of Signature Matrix, Signature MatrixHX, and Signature Cord, and your destruction of product inventory, it appears that you have addressed the violation(s) detailed in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of your corrective actions.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, their implementing regulations, or 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:
03/06/2025
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Sol-Millennium Medical Inc.
MARCS-CMS 677524 —
December 22, 2025
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Liang Lin
Recipient Title
CEO
Sol-Millennium Medical Inc.
311 S Wacker Drive
Suite 4100
Chicago
,
IL
60606-6604
United States
llin@sol-m.com
Issuing Office:
Division of Medical Device and Radiological Health Operations Central
United States
Secondary Issuing Offices
United States
Dear Mr. Lin:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #677524, dated March 18, 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/
For 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:
01/05/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Tarmac Products, Inc.
MARCS-CMS 595993 —
September 18, 2025
Reference #:
FEI 1025483
Product:
Drugs
Recipient:
Recipient Name
Mr. Adalberto R. Cabrera
Recipient Title
Chief Operating Officer
Tarmac Products, Inc.
16311 NW 52nd AVE
Miami Gardens
,
FL
33014-6209
United States
Issuing Office:
Division of Medical Device and Radiological Health Operations Central
United States
Secondary Issuing Offices
United States
Dear Mr. Cabrera:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (Case 595993), dated November 9, 2020.
Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.
The 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/
Marisa Heayn
Compliance Officer
Division of Drug Quality II
Content current as of:
09/25/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Thermavis
MARCS-CMS 613564 —
March 25, 2025
Product:
Medical Devices
Recipient:
Recipient Name
Mark Norman Nightingale
Thermavis
19 Heather Park Drive
London, England
HA0 1SS
United Kingdom
markn@transputec.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mark Norman Nightingale:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 613564, dated March 4, 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
Office of Health Technologies 3 - Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
03/25/2025
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Thermoteknix Systems Ltd
MARCS-CMS 613565 —
March 25, 2025
Product:
Medical Devices
Recipient:
Recipient Name
Richard Sydney Salisbury Geraldine Anne Salisbury
Thermoteknix Systems Ltd
Teknix House, 2 Pembroke Avenue
Waterbeach, Cambridge
CB25 9QR
United Kingdom
richard.salisbury@thermoteknix.com
g.salisbury@thermoteknix.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Richard and Geraldine Salisbury:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 613565, dated March 4, 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
Office of Health Technologies 3 - Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
03/28/2025
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasa
MARCS-CMS 649158 —
July 10, 2025
Delivery Method:
Via Email
Product:
Medical Devices
Recipient:
Recipient Name
Mehmet Kayabaş
Recipient Title
Co-Founder & Chairman of the Board
Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasa
Akcaburgaz Mahallesi, Muhsin Yazicioglu Caddesi No:45/5
34522
Esenyurt
/
İstanbul
Turkey
mehmet.kayabas@turkuazsaglik.com.tr
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. Kayabaş:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS # 649158, dated December 29, 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/
Robert Ochs, Ph.D.
Director
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Cc:
Michael Scott
ST&T Research International, Inc.
88 McFaul Way
Zephyr Cove, Nevada 89448
mscott@sttresearch.com
Content current as of:
07/21/2025
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Walgreen Company
MARCS-CMS 662158 —
December 19, 2025
Delivery Method:
Via Email
Reference #:
2512 CMS 662158
Product:
Drugs
Recipient:
Recipient Name
Jessica Martinez
Walgreen Company
200 Wilmot Rd, MS#2114
Deerfield
,
IL
60015
United States
jessica.martinez@walgreens.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Jessica Martinez:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2512 (662158). Based on our evaluation, it appears that you have addressed the deficiencies identified in the warning letter by updating the listing file for Walgreens Sensitive Extra Whitening, NDC 0363-1588. Future FDA regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. 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/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
cc:
Elena Kraus                                Danielle Gray
Elena.Kraus@Walgreens.com    Danielle.gray1@wba.com
Content current as of:
12/30/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Warbucks Seafood NY LLC
MARCS-CMS 682870 —
April 17, 2025
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Raymond Mizrahi
Recipient Title
President
Warbucks Seafood NY LLC
1581 McDonald Avenue
Brooklyn
,
NY
11230-5512
United States
Issuing Office:
Division of Northeast Imports
United States
Secondary Issuing Offices
United States
Dear Mr. Mizrahi,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 682870 dated July 24, 2024. Based on our evaluation, it appears that you have addressed the violation 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/
Anna Alexander
Director, Compliance Branch
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration
Content current as of:
04/17/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Westminster International Ltd
MARCS-CMS 613566 —
March 25, 2025
Product:
Medical Devices
Recipient:
Recipient Name
Peter Fowler
Westminster International Ltd
Westminster House, Blacklocks Hill (Banbury Lane)
Banbury, Oxfordshire
OX17 2BS
United Kingdom
p.fowler@wg-plc.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Peter Fowler:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 613566, dated March 4, 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
Office of Health Technologies 3 - 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:
03/31/2025
Regulated Product(s)
Medical Devices