tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
MARCS-CMS 642792 —
January 27, 2026
Delivery Method:
VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED
Product:
Drugs
Recipient:
Recipient Name
Justin K. Graves
Recipient Title
Vice President
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
1736 North Greenville Avenue
Richardson
,
TX
75081-1808
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
Secondary Issuing Offices
United States
Dear Mr. Graves:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #642792, issued on November 18, 2022. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Matthew J. Lash
Acting Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
03/20/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
NSE Products, Inc. DBA Nu Skin Enterprises, Inc.
MARCS-CMS 722667 —
July 14, 2026
Delivery Method:
Via Electronic Mail - Delivery and Read Receipt Requested
Reference #:
3093 CMS 722667
Product:
Drugs
Recipient:
Recipient Name
Ryan Napierski
Recipient Title
Chief Executive Officer
NSE Products, Inc. DBA Nu Skin Enterprises, Inc.
75 West Center Street
Provo
,
UT
84601
United States
rsnapier@nuskin.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
To Ryan Napierski:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 3093 (722667). Based on our evaluation, it appears that your firm has addressed deficiencies identified in the warning letter by updating the drug listings for “AP-24 Fluoride,” NDC 62839-1151; “AP-24,” NDC 62839-1152; “AP-24 Whitening,” NDC 62839- 1155; and an additional 61 drug listings that were out of compliance. 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.
Please note FDA posts close-out letters on www.fda.gov.
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:
07/21/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Nubratori, Inc. dba Nubratori Rx
MARCS-CMS 700513 —
July 27, 2026
Delivery Method:
VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT
Product:
Drugs
Recipient:
Recipient Name
Robert P. Nickell
Recipient Title
Chief Executive Officer
Nubratori, Inc. dba Nubratori Rx
381 Van Ness Avenue, Suite 1507
Torrance
,
CA
90501-7220
United States
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Nickell:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #700513, issued on January 22, 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
cc: Gulshakar Khwaja, RPH, MS, PharmD
Director of Regulatory Affairs
Content current as of:
07/30/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
OCPP, LLC
MARCS-CMS 615550 —
May 21, 2026
Delivery Method:
VIA EMAIL NO HARD COPY TO FOLLOW
Product:
Animal & Veterinary
Recipient:
Recipient Name
Olivia K.L. Hudson
Recipient Title
Owner
OCPP, LLC
OC Raw Dog LLC
1500 Commerce Street, Suite 101
Corona
,
CA
72878-3215
United States
olivia@ocpp.pet
Issuing Office:
Office of Human and Animal Food Operations- West Division 5
United States
Secondary Issuing Offices
United States
Dear Olivia Hudson,
The United States Food and Drug Administration has completed evaluation of your facility’s corrective actions in response to our Warning Letter CMS 615550, dated February 23, 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 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/
Stephen J. Rabe
Compliance Officer, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
Tel: 513-322-0660
Content current as of:
05/21/2026
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Philadelphia 7, Inc d/b/a Passional Boutique
MARCS-CMS 720843 —
March 27, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Dumesh Kankanamalage
Recipient Title
Chief Executive Officer
Philadelphia 7, Inc d/b/a Passional Boutique
317 South St
Philadelphia
,
PA
19147
United States
manager@passionalboutique.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Dumesh Kankanamalage:
The Food and Drug Administration (FDA) has completed an evaluation of Philadelphia 7, Inc d/b/a Passional Boutique corrective actions in response to our Warning Letter CMS #720843, 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
Dumesh Kankanamalage
Philadelphia 7, Inc
cc: passionalstaff@gmail.com
Content current as of:
04/06/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Quality CDMO, Inc.
MARCS-CMS 665961 —
May 01, 2026
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Anin Shakiba
Recipient Title
President
Quality CDMO, Inc.
5000 South Freeway, Suite 106
Fort Worth
,
TX
76115
United States
a.shakiba@qcdmo.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Shakiba:
The U.S. Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 665961) dated September 11, 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 ensure 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/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Content current as of:
05/11/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Rontis Hellas S.A.
MARCS-CMS 695160 —
February 26, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Anastasios Politopoulos
Recipient Title
CEO
Rontis Hellas S.A.
Rontis Hellas S.A. Industrial Area of Larissa
41500
Larissa, Thessaloniki
Greece
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. Anastasios Politopoulos:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #695160 dated October 28, 2024). Based on our evaluation of the evidence provided in your Warning Letter response #5 (received by FDA on December 31, 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/
for Bram Zuckerman, MD
Director
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Jessica Osward-McLeod
Nipro Medical Corporation
3150 NW 107th Ave.
Miami, Florida 33172, USA
jessicao@nipromed.com
Content current as of:
03/12/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Similasan AG
MARCS-CMS 658878 —
July 29, 2026
Reference #:
FEI 1000110034
Product:
Drugs
Recipient:
Recipient Name
Dr. Urs Lehmann
Recipient Title
CEO
Similasan AG
Industriestrasse 27
Sarnen
6060
Switzerland
Urs.lehmann@similasan.swiss
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
Dear Dr. Lehmann and Mr. Quail:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 658878, dated September 11, 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/
Kevin Maguire
Compliance Officer
Division of Drug Quality III
Office of Manufacturing Quality
Content current as of:
07/30/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Sperm Bank, Inc. dba Fertility Center of California
MARCS-CMS 694273 —
February 09, 2026
Delivery Method:
Via Email
Product:
Biologics
Recipient:
Recipient Name
Martin D. Bastuba, M.D.
Recipient Title
Owner/Medical Director
Sperm Bank, Inc. dba Fertility Center of California
6699 Alvarado Road, Suite 2208
San Diego
,
CA
92120
United States
Director@fertilityCTR.com
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Secondary Issuing Offices
United States
Dear Dr. Bastuba:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter CBER 25-694273 dated February 14, 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 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:
02/19/2026
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Strive Pharmacy Texas LLC dba Strive Pharmacy
MARCS-CMS 639220 —
May 13, 2026
Delivery Method:
VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT
Product:
Drugs
Recipient:
Recipient Name
Nathan Hill
Recipient Title
Chief Executive Officer
Strive Pharmacy Texas LLC dba Strive Pharmacy
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne
3975 East Mesquite Street
Gilbert
,
AZ
85296
United States
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
Secondary Issuing Offices
United States
Dear Mr. Hill:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #639220, issued on August 29, 2022. 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:
05/28/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Tailstorm Health Inc. dba Medivant Health
MARCS-CMS 703497 —
March 23, 2026
Delivery Method:
VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT
Product:
Drugs
Recipient:
Recipient Name
Viraj Gandhi
Recipient Title
Chief Executive Officer
Tailstorm Health Inc. dba Medivant Health
24416 N. 19th Avenue Suite 200
Phoenix
,
AZ
85085-1400
United States
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Gandhi:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #703497, issued on April 8, 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:
04/14/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
TG Supply LLC d/b/a TransGuy Supply
MARCS-CMS 720846 —
March 27, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Anthony Guajardo
Recipient Title
Director
TG Supply LLC d/b/a TransGuy Supply
722 S Wildwood Dr
Irving
,
TX
75060
United States
abuse@transguysupply.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Anthony Guajardo:
The Food and Drug Administration (FDA) has completed an evaluation of TG Supply LLC d/b/a TransGuy Supply corrective actions in response to our Warning Letter CMS #720846, 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
cc: Shopify, Inc.
abuse@shopify.com
Content current as of:
04/06/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
For Them, Inc.
MARCS-CMS 720839 —
March 27, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Kylo Freeman
Recipient Title
Founder
For Them, Inc.
122 East 42nd St., 18th Floor
New York
,
NY
10168
United States
legal@forthem.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Kylo Freeman:
The Food and Drug Administration (FDA) has completed an evaluation of For Them, Inc. corrective actions in response to our Warning Letter CMS #720839, 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
Anthony Guajardo
TG Supply LLC d/b/a TransGuy Supply
cc: Shopify, Inc. abuse@shopify.com
cc: abuse@forthem.com; team@forthem.com
Content current as of:
03/31/2026
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Thrive Health and Wellness, LLC dba Thrive Health Solutions
MARCS-CMS 714891 —
July 27, 2026
Delivery Method:
Via Electronic Mail - Delivery and Read Receipt Requested
Product:
Drugs
Recipient:
Recipient Name
Doug Hatch
Recipient Title
Owner
Thrive Health and Wellness, LLC dba Thrive Health Solutions
88 Inverness Circle East, Ste A-204
Englewood
,
CO
80112-5521
United States
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Hatch:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #714891, issued on February 9, 2026. 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:
08/06/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
TomboyX, PBC
MARCS-CMS 720849 —
March 27, 2026
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Fran Dunaway
Recipient Title
President
TomboyX, PBC
2200 Western Avenue
Seattle
,
WA
98121
United States
legal@tomboyx.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Fran Dunaway:
The Food and Drug Administration (FDA) has completed an evaluation of TomboyX, PBC corrective actions in response to our Warning Letter CMS #720849, 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
cc: Shopify, Inc. abuse@shopify.com
cc: abuse@tomboyx.com; info@tomboyx.com
Content current as of:
04/07/2026
Regulated Product(s)
Medical Devices