tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
D.A.Y. Farm
MARCS-CMS 591433 —
November 18, 2022
Product:
Food & Beverages
Recipient:
Recipient Name
Daniel A. Yoder
Recipient Title
Owner
D.A.Y. Farm
13007 Keller Drive
Saint Charles
,
MN
55972-4077
United States
Issuing Office:
Office of Human and Animal Foods - West Division 1
United States
Dear Mr. Yoder:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated November 20, 2019. 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/
Dianna C. Sonnenburg
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
11/21/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Deva Holding AS - Cerkezkoy Subesi
MARCS-CMS 577493 —
December 23, 2022
Reference #:
320-19-33
Product:
Drugs
Recipient:
Recipient Name
Ms. Refiye Adiyaman
Recipient Title
Manager, Quality Operations Group
Deva Holding AS - Cerkezkoy Subesi
Halkalı Merkez Mah. Basın Expres Caddesi No:1
34303
Küçükçekmece
/
İstanbul
Turkey
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Ms. Adiyaman,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-33 dated August 6, 2019.
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 and/or deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
for Joan Johnson
Compliance Officer
Division of Drug Quality I
Content current as of:
01/12/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Diasol Inc.
MARCS-CMS 535734 —
March 15, 2022
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Monica F. Abeles
Recipient Title
President
Diasol Inc.
310 S 43rd Ave.
Ste B
Phoenix
,
AZ
85009
United States
mabeles@diasol.com
Issuing Office:
Los Angeles District Office
United States
Dear Ms. Abeles:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #535734-17) dated September 25, 2017. 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/
Jessica Mu
Director, Compliance Branch
Office of Medical Device and Radiological Health Operations
Division 3
Content current as of:
03/23/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Duoc Thao Tre Xanh, LLC
MARCS-CMS 611685 —
April 01, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
22-HAFE4-WLCOL-08
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Tin Huynh
Recipient Title
Owner
Duoc Thao Tre Xanh, LLC
9724 N Armenia Avenue
Suite 401a
Tampa
,
FL
33612-7550
United States
Tinhuynh@gmail.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Dear Mr. Huynh:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 21-HAFE4-WL-02 dated March 16, 2021. It appears that you have addressed the violations contained in this Warning Letter since the firm has been dissolved.
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.
Kind regards,
/S/
Pearl Lopina
Director of Compliance Branch
OHAFO East Division IV
Content current as of:
04/19/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
E-Cig Outlet, LLC
MARCS-CMS 613472 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101508
Product:
Tobacco
Recipient:
Recipient Name
Mark Mills and Tom Wasilewski
E-Cig Outlet, LLC
United States
e-cigoutlet@comcast.net
(b)(6)
Issuing Office:
Center for Tobacco Products
United States
Dear Mark Mills and Tom Wasilewski:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your responses dated March 8, 2021, and March 18, 2021 in response to our Warning Letter dated February 26, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://e-cigoutlet.net.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation 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 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
GoDaddy.com, LLC
abuse@godaddy.com
Google, LLC
google-cloud-compliance@google.com
Content current as of:
06/10/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
E Vapor Hut LLC
MARCS-CMS 626435 —
July 01, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2201736
Product:
Tobacco
Recipient:
Recipient Name
April Hardy
E Vapor Hut LLC
United States
april@evaporhut.com
Issuing Office:
Center for Tobacco Products
United States
Dear April Hardy:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your letters dated February 7, 2022, in response to our Warning Letter dated February 4, 2022. Based on our evaluation, it appears that you have addressed the violation contained in the Warning Letter by no longer offering for sale e-liquids manufactured by you that were cited as not having market authorization on https://evaporhut.com to customers in the United States.
Our surveillance shows you continue to offer for sale to customers in the United States other tobacco products that may be subject to market authorization requirements. FDA encourages you to discuss with your suppliers the current status of any particular tobacco product’s marketing application or any product’s marketing authorization. For additional information regarding currently marketed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement, please visit our website https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-lists?utm_medium=email&utm_source=govdelivery#list%20of%20deemed.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic 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.
Sincerely,
/S/
Mallory Johnson
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
07/14/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
ECI Pharmaceuticals, LLC
MARCS-CMS 625254 —
March 16, 2022
Product:
Drugs
Recipient:
Recipient Name
John Copanos
ECI Pharmaceuticals, LLC
5311 NW 35th Terrace
Ft. Lauderdale
,
FL
33309
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Mr. Copanos,
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2267. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and corrected the data deficiencies. 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 to continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during additional data review projects, future inspections, or through other means.
Sincerely,
/S/
Carolyn E. Becker, J.D.
Director, Office of Unapproved Drugs & Labeling Compliance
Center for Drug Evaluation and Research Office of Compliance
U.S. Food and Drug Administration
Tel: 301-796-8801
carolyn.becker@fda.hhs.gov
CC: Florida District Office
Content current as of:
03/22/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
The Elderberry Company
MARCS-CMS 608837 —
January 26, 2022
Delivery Method:
VIA Electronic Mail
Product:
Dietary Supplements
Recipient:
Recipient Name
Jennifer C. Watson
Recipient Title
Owner
The Elderberry Company
302 Pearl Street Suite B
New Albany
,
IN
47150
United States
Issuing Office:
Office of Human and Animal Food Operations East-VI
United States
Dear Ms. Watson:
The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY20-HAFE6-WL-05, issued on 09/08/2020. Based on our evaluation, it appears the 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/
Kelli Wilkinson LCDR
Director of Compliance
Office of Human and Food Operations
Division East 6
Content current as of:
08/23/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
FF Vapors, LLC
MARCS-CMS 614679 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101585
Product:
Tobacco
Recipient:
Recipient Name
Angela Duschl
FF Vapors, LLC
United States
ffvapors@gmail.com
Dusj72@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Angela Duschl:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your response dated August 18, 2021 to our Warning Letter dated May 7, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://ffvapors.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation 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 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Tucows, Inc.
domainabuse@tucows.com
Squarespace, Inc.
Abuse-network@squarespace.com
Content current as of:
06/08/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Fujifilm Corporation
MARCS-CMS 546987 —
April 04, 2022
Product:
Medical Devices
Recipient:
Recipient Name
Henry Izawa
Recipient Title
President and CEO
Fujifilm Corporation
419 West Avenue
Stamford
,
CT
06902
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Henry Izawa:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 546987, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) 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 during a subsequent inspection or through other means.
Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Center for Devices and Radiological Health
CC:
Randy Vader
Vice President, Quality and Regulatory Affairs and Corporate Compliance Officer
Fujifilm Medical Systems U.S.A., Inc.
419 West Avenue
Stamford, Connecticut 06902
Keith Nelson
Director of Infection Control and Quality Assurance
10 Highpoint Drive
Wayne, New Jersey 07470
Mr. Teiichi Goto
Corporate Vice President
General Manager
Medical System Business Division
Research & Development Management Headquarters
Fujifilm Corporation
798, Miyanodai Kaisei-Machi
Ashigarakami-Gun
Kanagawa 258-8538 Japan
Jennifer Henderson
Partner, Hogan Lovells US LLP
Columbia Square
555 Thirteenth Street, NW
Washington, DC 20004
John J. Smith, MD, JD
Legal Counsel at Hogan Lovells US LLP
Columbia Square
555 Thirteenth Street, NW
Washington, DC 20004US AGENT
US AGENT ADDRESS
Content current as of:
04/08/2022
Regulated Product(s)
Medical Devices
WARNING LETTER
Glicerinas Industriales, S.A. de C.V.
MARCS-CMS 633340 —
June 13, 2022
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Mr. Alfredo Moran Sanchez
Recipient Title
Director
Glicerinas Industriales, S.A. de C.V.
Calle Uranio No. 80
Col. Arenales Tapatios
45188
Zapopan
,
Jal.
Mexico
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Warning Letter 320-22-15
June 13, 2022
Dear Mr. Sanchez:
The U.S. Food and Drug Administration (FDA) notified your site, Glicerinas Industriales, S.A. de C.V. (“GLINSA”), FEI 3016420687, at Calle Uranio No. 80, Col. Arenales Tapatios, Zapopan, of a planned inspection of your drug manufacturing facility from May 16 to May 20, 2022. Your firm refused the pre-announced inspection during a phone call with representatives from the Office of Regulatory Affairs on February 24, 2022, and written notification received by your firm via United Parcel Service (UPS) on March 23, 2022.
Your firm is a supplier of drug components (e.g., glycerin) to manufacturers of finished drug products distributing to the U.S. market. The use of glycerin contaminated with diethylene glycol (DEG) has resulted in various lethal poisoning incidents in humans worldwide.
See FDA’s guidance document Testing of Glycerin for Diethylene Glycol for FDA’s current thinking regarding current good manufacturing practice (CGMP) requirements when manufacturing drugs containing glycerin at
https://www.fda.gov/media/71029/download
.
Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.
See FDA’s guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, at
https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm360484.pdf
.
FDA placed your firm on Import Alert 66-79 on June 9, 2022.
Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Glicerinas Industriales, S.A. de C.V., Calle Uranio No. 80, Col. Arenales Tapatios, Zapopan, into the United States that appear to be adulterated are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3016420687 and ATTN: Bill Fowler.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
06/21/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Great Healthworks, Inc.
MARCS-CMS 611686 —
January 25, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
21-HAFE4-WL-06
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Ken Meares
Recipient Title
Chief Executive Officer
Great Healthworks, Inc.
4150 SW 28th Way
Fort Lauderdale
,
FL
33312-5201
United States
komorris@greathealthworks.com
lpagan@healthworks.com
Issuing Office:
Office of Human and Animal Food Operations, Division IV East
United States
(787) 729-8500
Dear Mr. Meares:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, 21-HAFE4-WL-06 dated June 23, 2021. 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/
Pearl Lopina
Director of Compliance Branch
Office of Human and Animal Food
Operations, East Division IV
Content current as of:
02/02/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Greiner Bio-One North America, Inc.
MARCS-CMS 606266 —
April 25, 2022
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Arnaldo C. Marchionne
Recipient Title
Chairman of the Management Board
Greiner Bio-One North America, Inc.
4238 Capital Drive
Monroe
,
NC
28110
United States
a.c.marchionne@gbo.com
Manfred.abel@gbo.com
Issuing Office:
Division of Medical Device and Radiological Health Operations Central
United States
(407) 475-4700
Dear Mr. Marchionne:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 606266) issued on April 16, 2020. Based on our evaluation, it appears that you have addressed the violations(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/
Melissa Michurski,
Director Compliance Brach
Office of Medical Device and Radiological Health Division 2
Content current as of:
04/27/2022
Regulated Product(s)
Medical Devices