tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Aurora Pharmaceutical, Inc.
MARCS-CMS 698797 —
September 11, 2025
Product:
Animal & Veterinary
Recipient:
Recipient Name
Attention: Michael Strobel, DVM, MS
Recipient Title
CEO
Aurora Pharmaceutical, Inc.
1196 Highway 3 South
Northfield
,
MN
55057
United States
Issuing Office:
Center for Veterinary Medicine
United States
Secondary Issuing Offices
United States
Dear: Dr. Strobel
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, February 7, 2025. 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 #698797
Sincerely,
/S/
Linda Walter-Grimm, DVM
Director, Division of Pharmacovigilance and Surveillance
Office Surveillance and Compliance
Center for Veterinary Medicine
Content current as of:
09/19/2025
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Beckman Coulter, Inc.
MARCS-CMS 678042 —
April 04, 2025
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Kevin O’Reilly
Recipient Title
President
Beckman Coulter, Inc.
Beckman Coulter Diagnostics
1000 Lake Hazeltine Drive
Chaska
,
MN
55318-1037
United States
Koreilly@DHDiagnostics.com
Issuing Office:
Division of Medical Device and Radiological Health Operations Central
United States
Secondary Issuing Offices
United States
Dear Mr. O’Reilly:
The Food and Drug Administration has completed an evaluation of Beckman Coulter Inc.’s corrective actions in response to our Warning Letter (CMS # 678042, March 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/
Matthew G. Hillebrenner
Deputy Director
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
04/10/2025
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Bernardo Farms, LLC.
MARCS-CMS 686727 —
September 19, 2025
Delivery Method:
ELECTRONIC MAIL
Product:
Food & Beverages
Recipient:
Recipient Name
Lordson Jim Valenzuela Bernardo, Jimmy Valenzuela Bernardo, Jr.
Recipient Title
Co-owners
Bernardo Farms, LLC.
15-3120 Pahoa Kapoho Rd
Pahoa
,
HI
96778
United States
bernardofarms808@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Secondary Issuing Offices
United States
Dear Messrs. Bernardo:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 686727, issued September 25, 2024. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
William Rennells
Acting Branch Chief
Produce Enforcement Branch
Office of Compliance and Enforcement
The Human Foods Program
Content current as of:
09/25/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Bioiberica, SAU
MARCS-CMS 629115 —
January 15, 2025
Reference #:
FEI 1000418405
Product:
Drugs
Recipient:
Recipient Name
Mr. Luis Solera Blasco
Recipient Title
Chief Executive Officer
Bioiberica, SAU
Carrer Antic Cami de Tordera 109-119
08389
Palafolls
Barcelona
Spain
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Luis Solera Blasco:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-22-20 dated June 30, 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/
Rokhsana Safaai-Jazi
Compliance Officer
Division of Drug Quality II
Content current as of:
01/29/2025
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Brewing Market Coffee
MARCS-CMS 682451 —
July 22, 2025
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Artine G Yapoujian
Recipient Title
Owner/President
Brewing Market Coffee
Harouts Inc. dba Brewing Market Coffee
5775 Arapahoe Ave
Boulder
,
CO
80303-1331
United States
artine@brewingmarketcoffee.com
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
Secondary Issuing Offices
United States
Dear Mr. Yapoujian:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, CMS# 682451 dated April 25, 2024. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Robyn R. Jones, Branch Chief
Conventional Foods Enforcement Branch 2
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
12/16/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Centaur Pharmaceuticals Private Ltd.
MARCS-CMS 651080 —
December 03, 2025
Reference #:
FEI 3003973520
Product:
Drugs
Recipient:
Recipient Name
Santosh Badhe
Recipient Title
Vice President
Centaur Pharmaceuticals Private Ltd.
Plot No. 75, 76 & 76/1, & 74 Chikhloli MIDC
Ambernath-West
Thane
421501
Maharashtra
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
Dear Mr. Badhe:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-15 dated June 5, 2023.
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:
07/21/2026
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Choo's Enterprises Ltd
MARCS-CMS 683922 —
May 27, 2025
Product:
Food & Beverages
Recipient:
Recipient Name
Edwin Cho
Recipient Title
CEO
Choo's Enterprises Ltd
Jordan's Complex
Saint Michael
,
Barbados
Barbados
echo@choosenterprises.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Secondary Issuing Offices
United States
Dear Mr. Edwin Cho:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #683922, issued June 3, 2024. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Victoria Wagoner, Acting Branch Chief
Conventional Foods Enforcement Branch 1
Division of Conventional Foods Enforcement
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
06/03/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Deymed Diagnostic s.r.o.
MARCS-CMS 671076 —
August 06, 2025
Product:
Medical Devices
Recipient:
Recipient Name
Kamil Holub
Recipient Title
CEO
Deymed Diagnostic s.r.o.
Kudrnacova 533
Hronov
54931
Nachod
Czechia
Issuing Office:
OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality
United States
Secondary Issuing Offices
United States
Dear Kamil Holub:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 671076, dated November 7, 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/
for David McMullen, M.D.
Director OHT5: Office of Neurological
and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Robert V. Packard (U.S. Agent)
Medical Device Academy Inc.
Shrewsbury, VT US 05738
Email: Rob@13485cert.com
Content current as of:
08/12/2025
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Elanco Animal Health
MARCS-CMS 695170 —
September 11, 2025
Product:
Animal & Veterinary
Recipient:
Recipient Name
Attention: Jeffrey Simmons
Recipient Title
President and CEO
Elanco Animal Health
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 28, 2025. 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 #695170.
Sincerely,
/S/
Linda Walter-Grimm, DVM
Director, Division of Pharmacovigilance and Surveillance
Office Surveillance and Compliance
Center for Veterinary Medicine
Content current as of:
09/19/2025
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Fides New York Inc.
MARCS-CMS 608989 —
April 23, 2025
Product:
Food & Beverages
Recipient:
Recipient Name
Tae Shin
Recipient Title
Owner
Fides New York Inc.
4725 208th Street
Bayside
,
NY
11361-3208
United States
Issuing Office:
Division of Northeast Imports
United States
Secondary Issuing Offices
United States
Dear Mr. Tae Shin,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 608989 dated July 29, 2020. 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
U.S. Food and Drug Administration
Content current as of:
04/28/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Healthwest Minerals, Inc. dba Mt. Capra Products
MARCS-CMS 685115 —
September 03, 2025
Delivery Method:
Via Email Delivery Confirmation
Product:
Dietary Supplements
Recipient:
Recipient Name
Joseph C. Stout
Recipient Title
President
Healthwest Minerals, Inc. dba Mt. Capra Products
279 Southwest 9th Street
Chehalis
,
WA
98532-3313
United States
joe@mtcapra.com
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
Secondary Issuing Offices
United States
Dear Mr. Stout:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 685115, 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 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/
Acting Branch Chief
Division of Conventional Foods Enforcement – Branch 1
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
09/08/2025
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Ice Cream House LLC
MARCS-CMS 686641 —
December 04, 2025
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Avigdor Klein, Mr. David Klein
Recipient Title
Co-Owners
Ice Cream House LLC
2 Church Avenue
Brooklyn
,
NY
11218-3096
United States
victor@koshericecream.com
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Secondary Issuing Offices
United States
Dear Messrs. Klein:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #686641, issued September 24, 2024. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Victoria Wagoner, Acting Branch Chief
Conventional Foods Enforcement Branch 1
Division of Conventional Foods Enforcement
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
12/16/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
IndulgeRx Brands, Inc
MARCS-CMS 703668 —
November 21, 2025
Delivery Method:
Via Email with Confirmation of Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. John Hastings
Recipient Title
Founder and CEO
IndulgeRx Brands, Inc
1273 S 1800 W, Unit 13
Woods Cross
,
UT
84087-2551
United States
jhastings@fightbackfoods.com
Issuing Office:
Human Foods Program
United States
Secondary Issuing Offices
United States
Dear Mr. Hastings:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 703668, dated June 16, 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.
We note that with your submitted corrective actions, you included product labeling for review. Please note that our program experts do not provide product label approval. We offer the following comments for your consideration:
We recommend clarifying the saturated fat statement to provide greater transparency and help consumers understand that your product meets FDA healthy claim requirements while avoiding potential misinterpretation about the actual saturated fat content. The current labeling states "HEALTHY* NO MORE THAN 1g SAT FAT (Nuts are Exempt*)" while your product appears to contain more than 1g of saturated fat. You may want to consider alternative statements that emphasize that your product meets “Healthy” claim criteria for Saturated Fat or that clarify at the top of your labels that the product meets FDA “Healthy” claim requirements to establish clear context that references the healthy claim criteria.
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/
Branch Chief
Division of Critical Foods Labeling and Dietary Supplement Enforcement
Critical Foods and Labeling Enforcement Branch
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
12/01/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Kalchem International, Inc.
MARCS-CMS 607098 —
March 20, 2025
Reference #:
FEI 1000149906
Product:
Drugs
Recipient:
Recipient Name
Ms. Kalyn R. Tabor
Recipient Title
President, Owner
Kalchem International, Inc.
224 S. Main St Ste B
Lindsay
,
OK
73052
United States
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
Secondary Issuing Offices
United States
Dear Ms. Tabor:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Case # 607098 dated August 27, 2020.
Based on our evaluation, it appears that you have addressed the violations and 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 violations and deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Chhaya Shetty
Compliance Officer
Division of Drug Quality I
Content current as of:
03/24/2025
Regulated Product(s)
Drugs