tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Cutera, Inc.
MARCS-CMS 639552 —
March 09, 2023
Product:
Medical Devices
Recipient:
Recipient Name
David H. Mowry
Recipient Title
CEO
Cutera, Inc.
3240 Bayshore Blvd.
Brisbane
,
CA
94005
United States
dmowry@cutera.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear David H. Mowry:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 639552, dated November 10, 2022). 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/
Courtney H. Lias, Ph.D.
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:
John J. Smith, M.D., J.D.
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington, DC 20004
john.smith@hoganlovells.com
Content current as of:
10/18/2024
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
CytoDyn, Inc.
MARCS-CMS 626957 —
April 27, 2023
Product:
Drugs
Recipient:
Recipient Name
Cyrus Arman, Ph.D., M.B.A.
Recipient Title
President
CytoDyn, Inc.
1111 Main Street
Suite 660
Vancouver
,
WA
98660
United States
Issuing Office:
The Office of Prescription Drug Promotion (OPDP)
United States
Dear Dr. Arman:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated February 11, 2022. Based on our evaluation, it appears that you have addressed the violations contained in this 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 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 direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 3 in addition to the IND number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to the OPDP RPM at CDER-OPDP-RPM@fda.hhs.gov.
Sincerely,
{See appended electronic signature page}
Samuel M. Skariah, PharmD, RAC
Team Lead
Division of Advertising & Promotion Review 1
Office of Prescription Drug Promotion
--------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
--------------------------------------------------------------------------------------------
/s/
------------------------------------------------------------
SAMUEL M SKARIAH
04/27/2023 02:50:30 PM
Content current as of:
07/25/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
DENTON VAPE SHOPPE
MARCS-CMS 619305 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100278
Product:
Tobacco
Recipient:
Recipient Name
William Guynes
DENTON VAPE SHOPPE
United States
dentonvapeshoppe@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear William Guynes:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has completed evaluation of your corrective actions in response to FDA’s October 19, 2021 Warning Letter. Based on our evaluation, it appears that you have taken steps to address 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 ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
It is your responsibility to ensure that all of your tobacco products and all related labeling and/or advertising on any websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
If you have any questions, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/
Chad Burger
Director
Division of Product Compliance
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
09/11/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Desert Premium Group, LLC
MARCS-CMS 612030 —
January 03, 2023
Delivery Method:
UPS Next Day Air
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Rob W. Holland
Desert Premium Group, LLC
Creo Capital Partners
6455 S. Yosemite St.
Suite 140
Greenwood Village
,
CO
80111
United States
Issuing Office:
Office of Human and Animal Foods Division IV West
United States
Dear Mr. Holland:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter # 612030, dated December 2, 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 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/
E.Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
Content current as of:
01/13/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Dexcowin Co. Ltd.
MARCS-CMS 545388 —
October 25, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Raymond Ryu
Recipient Title
CEO
Dexcowin Co. Ltd.
901~905 25 Gasan Digital 1-Ro
Geumcheon-gu
Seoul
08594
South Korea
sbryu@dexcowin.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Ryu:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letters (CMS Case No. 545388, dated February 20, 2018, and CMS Case No. 474468, dated August 11, 2015). Based on our evaluation, it appears that you have addressed the violations contained in these Warning Letters. 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:
Joyce St. Germain
U.S. Agent
The 510k Consulting, LLC
1449 Springleaf Drive
Ormond Beach, Florida 32174
Joyce510kfda@gmail.com
Content current as of:
11/07/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
DFA Dairy Brands, LLC
MARCS-CMS 590821 —
August 31, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Alan Bernon
Recipient Title
CEO
DFA Dairy Brands, LLC
Friendly's Manufacturing and Retail LLC
2711 North Haskell Ave
Suite 3400
Dallas
,
TX
75204
United States
Issuing Office:
Office of Human and Animal Food Operations East - Division 1
United States
Dear Mr. Bernon:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 590821, issued on November 22nd, 2019 for your facility located at 1855 Boston Road, Wilbraham, MA 01095-1002. 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/
Latoya Griffith
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
09/11/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Dianne's Fine Desserts
MARCS-CMS 600026 —
February 07, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Gregory M. Knowles
Recipient Title
CEO
Dianne's Fine Desserts
4 Graf Road
Newburyport
,
MA
01950
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 1
United States
Dear Mr. Knowles:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 600026, issued on March 2nd, 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 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/
Lillian Aveta
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
02/17/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
DLG Naturals, Inc.
MARCS-CMS 622277 —
July 20, 2023
Product:
Dietary Supplements
Recipient:
Recipient Name
Mary Jo Knueppel
Recipient Title
Chief Executive Officer
DLG Naturals, Inc.
2949 Venture Drive
Suite 100
Janesville
,
WI
53546-8502
United States
Issuing Office:
Office of Human and Animal Food Operations – West Division 1
United States
Dear Ms. Knueppel:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 622277 dated April 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 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/
Boun M. Xiong
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
07/21/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Drug Depot, LLC., dba APS Pharmacy
MARCS-CMS 653740 —
October 11, 2023
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Rob Kilgore
Recipient Title
CEO
Drug Depot, LLC., dba APS Pharmacy
Belmar Pharma Solutions
12860 W. Cedar Drive, Suite 211
Lakewood
,
CO
80228
United States
rob@belmarpharma.com
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
Dear Mr. Kilgore:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [Case #653740] issued on March 31, 2023, for Drug Depot, LLC dba APS Pharmacy, located at 34911 US Highway 19 N, Ste 600, Palm Harbor, FL 34684. 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/
Ronda Loyd-Jones
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
cc: Via Electronic Mail
Anne Szilagyi, VP of Quality
Belmar Pharma Solutions
12860 W. Cedar Dr., Suite 211
Lakewood, CO 80228
Email: anne.szilagyi@belmarpharma.com
Andrew M. Vukadinovich
Director of Operations
Drug Depot, LLC., dba APS Pharmacy
34911 US Highway 19N, Ste 600
Palm Harbor, FL 34684-1921
Email: andyv@aspsmeds.com
Content current as of:
10/30/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Dubak Electrical Group
MARCS-CMS 613511 —
July 20, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Nebojsa “Nick” Dubak
Recipient Title
Chief Operating Officer
Dubak Electrical Group
10 Beach Avenue
LaGrange
,
IL
United States
ndubak@dubakelectrical.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Nebojsa “Nick” Dubak:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613511, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed in the future.
Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
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:
07/24/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Dynamic Color, Inc.
MARCS-CMS 587250 —
January 30, 2023
Product:
Dietary Supplements
Recipient:
Recipient Name
Leonard Brass, Jeffery Roschman, Marcus Wingate
Recipient Title
Owners
Dynamic Color, Inc.
200 Park Central Boulevard S.
Suite 5
Pompano Beach
,
FL
33316
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Brass, Mr. Roschman, and Mr. Wingate,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #587250, issued September 18, 2019. 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/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/03/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
The Elderberry Fairy & Co., LLC
MARCS-CMS 622859 —
April 26, 2023
Product:
Dietary Supplements
Recipient:
Recipient Name
Catie Fasno
Recipient Title
Owner
The Elderberry Fairy & Co., LLC
3320 Electric Avenue
Lincoln Park
,
MI
48146
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 6
United States
Dear Ms. Fasno:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY2022-HAFE6-WL-08. Based on our evaluation, it appears that you have addressed the violation(s) 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/
LCDR Kelli L. Wilkinson
Compliance Branch Director
Content current as of:
04/28/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Elemental Vapor Bar
MARCS-CMS 613022 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100090
Product:
Tobacco
Recipient:
Recipient Name
Nicholas Van Burren
Elemental Vapor Bar
United States
evbshop@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Nicholas Van Burren:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has completed evaluation of your corrective actions in response to FDA’s February 12, 2021 Warning Letter. Based on our evaluation, it appears that you have taken steps to address 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 ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
It is your responsibility to ensure that all of your tobacco products and all related labeling and/or advertising on any websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
If you have any questions, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/s/
Chad Burger
Director
Division of Product Compliance
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
09/11/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
MARCS-CMS 610384 —
February 13, 2023
Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Dawn T. Hoang
Recipient Title
Co-Owner
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
6828 E. Brown Rd.
Ste. 101
Mesa
,
AZ
85207
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Ms. Hoang:
The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter, CMS 610384, issued September 8, 2020. 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/
CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
02/17/2023
Regulated Product(s)
Drugs