tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Florida Gold Foods LLC
MARCS-CMS 637153 —
June 21, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
23-HAFE4-WLCOL-03
Product:
Tobacco
Recipient:
Recipient Name
Mr. Ragindra Persaud, Mr. Daniel Sew
Recipient Title
Owner, General Manager
Florida Gold Foods LLC
1770 and 1780 Business Center Lane
Kissimmee
,
FL
34758-1800
United States
sew@floridagoldfoods.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Dear Mr. Persaud and Mr. Sew:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions as evidenced in our inspection conducted on June 1, 2023. This inspection served as a follow up to our Warning Letter, 23-HAFE4-WL-01 dated November 22, 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/
Pearl Lopina
Director of Compliance Branch OHAFO, Division IV East
Content current as of:
07/05/2023
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Forcemech International LLC
MARCS-CMS 634891 —
June 07, 2023
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Wenchao (David) Ou
Recipient Title
President & CEO
Forcemech International LLC
4111 Rice Drier Road
Ste. #1H
Pearland
,
TX
77581
United States
David.Ou@forcemech.com
Issuing Office:
Office of Medical Device and Radiological Health Division 3
United States
Dear Mr. Ou:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #634891) dated September 21, 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/
Jessica Mu
Director, Compliance Branch
Office of Medical Device and Radiological Health Operations
Division 3
Content current as of:
06/15/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Gary’s Cheesecakes & Fine Desserts
MARCS-CMS 654471 —
November 08, 2023
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Gary W. Haas
Recipient Title
Owner
Gary’s Cheesecakes & Fine Desserts
5285 Crookshank Road
Cincinnati
,
OH
45238
United States
garyscc3818@yahoo.com
Issuing Office:
Division of Human and Animal Food Operations East V
United States
Dear Mr. Haas:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter 654471, dated April 28, 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/
Christopher N. Dedeaux
Compliance Officer
Office of Human and Animal Foods Operations
Division 5 East
Content current as of:
11/17/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Getsch+Hiller Medizintechnik GmbH
MARCS-CMS 644680 —
September 20, 2023
Product:
Tobacco
Recipient:
Recipient Name
Mr. Werner M. Hiller
Recipient Title
Co-Owner
Getsch+Hiller Medizintechnik GmbH
Sattlerstrape 20
78532
Tuttlingen, Nendingen
Germany
werner.hiller@getsch-hiller.de
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Hiller:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS#644680, dated December 27, 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/
For,
Binita S. Ashar, MD, MBA, FACS
Director
Office of Surgery and Infection Control Devices
Office of Product Quality and Evaluation
Center for Devices and Radiological Health
Content current as of:
09/29/2023
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Gipsco Investment Corporation dba Lee Silsby Compounding Pharmacy
MARCS-CMS 557802 —
January 05, 2023
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Adam Israel
Recipient Title
CEO
Gipsco Investment Corporation dba Lee Silsby Compounding Pharmacy
23865 Mercantile Rd
Beachwood
,
OH
44122-5907
United States
adam@leesilsby.com
Issuing Office:
Detroit District Office
United States
Dear Mr. Israel:
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 #557802), dated July 10, 2018. 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/
Nicholas F. Lyons
Director, Compliance Branch
Division of Pharmaceutical Quality Operations III
Content current as of:
01/13/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
GPT Pharmaceuticals Private Ltd
MARCS-CMS 590938 —
June 02, 2023
Reference #:
FEI 3008311641
Product:
Drugs
Recipient:
Recipient Name
Mr. Ashok Adityan
Recipient Title
Managing Director
GPT Pharmaceuticals Private Ltd
11-1, C.I.E.E, Grandhinagar
Balanagar
Hyderabad
500037
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Adityan:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-13 dated December 17, 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 be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Lynnsey Renn, Ph.D.
Compliance Officer
Division of Drug Quality II
Content current as of:
06/06/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Great American Ventures LLC d/b/a Great American Vapes
MARCS-CMS 617946 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100235
Product:
Tobacco
Recipient:
Recipient Name
Raymond Odom
Great American Ventures LLC d/b/a Great American Vapes
United States
tony@greatamericanvapes.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Raymond Odom:
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 7, 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:
09/13/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
H2 Beverages, Inc.
MARCS-CMS 622917 —
March 22, 2023
Delivery Method:
UPS Overnight
Product:
Dietary Supplements
Recipient:
Recipient Name
Kurt H Ruppman, Sr.
Recipient Title
CEO/President
H2 Beverages, Inc.
1601 Summit Ave. Suite. 100
Plano
,
TX
75074-8109
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Secondary Issuing Offices
United States
Dear Mr. Ruppman:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 622917 dated June 14, 2022) issued following an inspection of your beverage manufacturing and distribution facility, located at 1601 Summit Ave Ste. 100, Plano, TX 75074-8109. 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/
Jessica E. Havranek
Director, Compliance Branch
Human & Animal Food Operations,
West Division 3
Cc: Lori Woznicki, Food and Drug Inspections Branch
Manager Division of Regulatory Services
Texas Department of State Health Services
1100 E. 49th Street – Mail Code 1987
Austin, Texas 78756
Content current as of:
12/14/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Hi Lyfe Vaporz, LLC
MARCS-CMS 614186 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101567
Product:
Tobacco
Recipient:
Recipient Name
Jostin A Iriarte
Hi Lyfe Vaporz, LLC
United States
info@hilyfevaporz.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Jostin A Iriarte:
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 April 9, 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:
09/13/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
HNC Products Inc.
MARCS-CMS 607359 —
February 02, 2023
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Vishnu Potini, MD
Recipient Title
President
HNC Products Inc.
1619 Commerce Parkway
Bloomington
,
IL
61704
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
Dear Dr. Potini:
We received your October 29, 2020; December 2, 2020; January 15, 2021; February 12, 2021; March 19, 2021; April 23, 2021; and February 16, 2022, letters in response to Warning Letter #607359. Your letters have been made a part of the Food and Drug Administration’s (FDA) permanent file for your firm.
The FDA has completed an evaluation of your corrective actions in response to the warning letter. Based on our evaluation, it appears that 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 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/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III
Content current as of:
02/09/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Human Biologics of Texas/Globus Medical
MARCS-CMS 557325 —
August 28, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Biologics
Recipient:
Recipient Name
Mr. Daniel Scavilla
Recipient Title
President/CEO
Human Biologics of Texas/Globus Medical
Tissue Transplant Technology, Ltd.
2560 Armistead Avenue
Audubon
,
PA
19403
United States
Issuing Office:
Los Angeles District Office
United States
Dear Mr. Scavilla:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, OBPO #19-01, issued October 30, 2018, directed towards your human cells, tissues, or cellular or tissue-based products (HCT/Ps) that meet all the criteria in 21 CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act (PHSA) [42 U.S.C. 264]. 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/
Marc Jackson, Compliance Officer
U.S. Food and Drug Administration
Office of Biological Products Operations, Division II
Compliance Branch
Marc.Jackson@fda.hhs.gov
Content current as of:
09/18/2023
Regulated Product(s)
Biologics
CLOSEOUT LETTER
ICA Health, LLC
MARCS-CMS 614383 —
October 16, 2023
Product:
Dietary Supplements
Recipient:
Recipient Name
Dr. James L. Wilson
Recipient Title
Owner/Manager
ICA Health, LLC
Future Formulations, LLC
1340 E. 20th Street
Tucson
,
AZ
85719-6710
United States
Issuing Office:
Office of Human and Animal Foods Operations – Division West 4
United States
Dear Dr. Wilson,
The Food and Drug Administration has completed an evaluation of ICA Health, LLC and Future Formulations, LLC corrective actions in response to our Warning Letter (CMS case #614383) issued on September 20, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
E.Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West
Division 4
Content current as of:
10/24/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Indoco Remedies Limited
MARCS-CMS 575313 —
May 01, 2023
Product:
Drugs
Recipient:
Recipient Name
Suresh G. Kare
Recipient Title
Chairman
Indoco Remedies Limited
Indoco House, 166 CST Road
Mumbai
400098
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mrs. Panandikar:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-29 dated July 9, 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 be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Joseph Lambert, Pharm.D.
Compliance Officer
Division of Drug Quality I
Content current as of:
05/08/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
International Golden Foods Inc
MARCS-CMS 619417 —
May 19, 2023
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Mansour Amiran
Recipient Title
Owner/CEO
International Golden Foods Inc
819 Industrial Drive
Bensenville
,
IL
60106
United States
info@goldenfood.com
Issuing Office:
Office of Human and Animal Food Operations East-VI
United States
Dear Mr. Amiran:
The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY22-HAFE6-WL-02, issued on 12/15/21. 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 continuing 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:
06/15/2023
Regulated Product(s)
Food & Beverages