tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Essense Of Life, LLC
MARCS-CMS 609001 —
January 28, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Larry McKaig
Essense Of Life, LLC
13114 U.S. Highway 160
Forsyth
,
MO
65653
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. McKaig:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 609001, issued October 9, 2020. 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 Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
02/02/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Exela Pharma Sciences LLC
MARCS-CMS 611316 —
April 30, 2021
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Phanesh Koneru, Ph.D., LL.M.
Recipient Title
President & CEO
Exela Pharma Sciences LLC
1245 Blowing Rock Blvd.
Lenoir
,
NC
28645
United States
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
Dear Dr. Koneru:
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 #: 611316; Date: April 8, 2021]. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. We acknowledge your firm’s intent to discontinue your 503B program, as stated in your warning letter response.
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,
Digitally signed by Dayna I. Martinez -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000369349,
cn=Dayna I. Martinez -S
Date: 2021.04.30 12:20:09 -04'00'
Dayna Martinez
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II
Content current as of:
02/11/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Fill It Pack It Inc
MARCS-CMS 570946 —
July 19, 2021
Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs
Recipient:
Recipient Name
Mr. Robert L. Miller
Recipient Title
Vice President and Co-owner
Fill It Pack It Inc
2555 E. Del Amo Blvd.
Compton
,
CA
90221
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
949-608-2900
Dear Mr. Miller:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your response to our Warning Letter (Ref CMS 570946) dated May 2, 2019. Based on our evaluation, it appears that you have adequately 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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
07/21/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Fixture Display LLC
MARCS-CMS 615052 —
September 27, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Alan Gao
Fixture Display LLC
2333 Wisconsin Ave.
Downers Grove
,
IL
60515
United States
cs@fixturedisplays.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Gao:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 615052, June 28, 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 yours,
/S/
Donna Engleman, MS, BSN
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
10/04/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Flavor Concepts LLC
MARCS-CMS 614179 —
July 16, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101565
Product:
Tobacco
Recipient:
Recipient Name
Susannah VanWinkle
Flavor Concepts LLC
United States
flavorconcepts7330@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Susannah VanWinkle,
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your Warning Letter responses dated April 27, 2021 and May 11, 2021, in response to our Warning Letter dated April 9, 2021. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter regarding your website https://conceptsinflavor.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Sincerely,
/S/
Mallory Bowling
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Flavor Concepts, LLC
info@karmacloudmaker.com
GoDaddy.com, LLC
abuse@godaddy.com
InMotion Hosting, Inc.
abuse@inmotionhosting.com
Content current as of:
07/21/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Fresh Express Inc Div of Chiquita Brands
MARCS-CMS 609899 —
November 10, 2021
Delivery Method:
Via Email
Reference #:
FY21-HAFE6-01
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. John P. Olivo
Recipient Title
President
Fresh Express Inc Div of Chiquita Brands
4757 The Grove Drive
Windermere
,
FL
34788
United States
jolivo@freshexpress.com
Issuing Office:
Office of Human and Animal Food Operations East -VI
United States
Dear Mr. Olivo,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY21-HAFE6-01. 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/
Kelli Wilkinson LCDR
Director of Compliance HAFE6 division
Content current as of:
11/29/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
FRS International, LLC
MARCS-CMS 606701 —
January 11, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Thomas C. Lines
FRS International, LLC
75 Arlington St
Ste 500
Boston
,
MA
02116-3936
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear: Mr. Thomas C. Lines,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our COVID-19 Warning Letter Re: 606701, issued May 13, 2020. Based on our evaluation, it appears 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,
Carrie J. Lawlor
/S/
Carrie Lawlor Branch Chief
Dietary Supplement and Labeling Assessment Branch Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrtion
Content current as of:
01/15/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Fujian Guangyang Egg Industry Company Limited
MARCS-CMS 594964 —
February 04, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jie Yu
Recipient Title
Chairman
Fujian Guangyang Egg Industry Company Limited
Hongxing Village
Jinyang Town
Fuqing Shi
Fuzhou Shi
Fujian Sheng
,
350303
China
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear: Mr. Yu:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 594964, issued December 26, 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/
Robyn R. Jones
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
03/26/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Fullest Closet
MARCS-CMS 606980 —
July 16, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001302
Product:
Tobacco
Recipient:
Fullest Closet
3975 Morgan Street
Pensacola
,
FL
32501
United States
support@fullestcloset.com
Issuing Office:
Center for Tobacco Products
United States
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions to our Warning Letter dated May 11, 2020. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter regarding your website, https://fullestcloset.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at
(301) 796-9235
or via email at
CTPCompliance@fda.hhs.gov
.
Sincerely,
/S/
Mallory Johnson
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Name.com, Inc.
abuse@name.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
07/21/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Gonzalez and Nietos, LLC
MARCS-CMS 561490 —
December 28, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
19-HAFE4-WL-03
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Andrew M. Gonzalez
Recipient Title
President
Gonzalez and Nietos, LLC
3320 NW 73rd St
Miami
,
FL
33147-5822
United States
agonzaleznietos@yahoo.com
Issuing Office:
San Juan District Office
United States
Dear Mr. Andrew M. Gonzalez, President:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our amended Warning Letter, 19-HAFE4-WL-03 dated November 29, 2018. 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.
Kind regards,
/S/
Laura Kennedy
Acting Director of Compliance Branch
Office of Human and Animal Food Operations Division IV East
Content current as of:
01/04/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
GPC Medical Ltd.
MARCS-CMS 536145 —
May 19, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Vikas Narang
Recipient Title
Owner
GPC Medical Ltd.
GPC Square, M Block, DDA LSC
Vikas Puri
110018
Delhi
India
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Vikas Narang:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 536145, dated October 20, 2017). 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/
CAPT Raquel Peat, PhD, MPH, USPHS
Director
OHT6: Office of Orthopedic Device
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
US Agent
Zachary Kelley
GPC Medical USA. Inc.
6060 N Central Expressway, Suite 560
Dallas, Texas US 75206
info@gpcmedicalusa.com
Content current as of:
05/24/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Grand Vapors
MARCS-CMS 613962 —
July 30, 2021
Delivery Method:
VIA Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Karisa Jones
Grand Vapors
United States
info@grandvapors.com
karisajones1414@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Karisa Jones,
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated March 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://www.grandvapors.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Sincerely,
/S/
Mallory Bowling
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
Cloudflare, Inc.
abuse@cloudflare.com
Content current as of:
08/16/2023
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Great Lakes Gelatin Company
MARCS-CMS 612323 —
November 05, 2021
Reference #:
FY21-HAFE6-03
Product:
Dietary Supplements
Recipient:
Recipient Name
James Burkett
Recipient Title
President
Great Lakes Gelatin Company
253 Commerce Dr.
Ste. 101
Grayslake
,
IL
60030
United States
JamesB@greatlakesgelatin.com
Issuing Office:
Office of Human and Animal Food Operations East-VI
United States
Dear Mr. Burkett,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY21-HAFE6-03. 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/
Kelli Wilkinson LCDR
Director of Compliance HAFE6 division
Content current as of:
11/05/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Green Explosion Inc
MARCS-CMS 609209 —
December 21, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
22-HAFE4-WLCOL-03
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Alejandro Gomez
Recipient Title
Director
Green Explosion Inc
6960 NW 25 Street
Miami
,
FL
33122
United States
accounting@greenexplosionherbs.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV
United States
(787) 729-8500
Dear Mr. Gomez:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to 20-HAFE4-WL-07, dated August 20, 2020. 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.
Kind regards,
/S/
Pearl Lopina
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
01/13/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
H & H Products Company
MARCS-CMS 565614 —
January 07, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
19-HAFE4-WL-02
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Morris L. Hartley, Jr.
Recipient Title
President
H & H Products Company
6600 Magnolia Homes Rd.
Orlando
,
FL
32810-4267
United States
morris@hhproductscompany.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Hartley:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 19-HAFE4-WL-02 dated November 15, 2018. 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.
Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
04/30/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Half Hill Farm Inc
MARCS-CMS 609440 —
September 22, 2021
Delivery Method:
Via Email
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Christian Grantham
Recipient Title
Owner
Half Hill Farm Inc
110 W. High Street
Woodbury
,
TN
37190
United States
halfhillfarm@gmail.com
Issuing Office:
Division of Human and Animal Food Operations East V
United States
Dear Mr. Grantham:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter 609440, dated November 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/
Christopher N. Dedeaux
Compliance Officer
Office of Human and Animal Foods Operations
Division 5 East
Content current as of:
09/28/2021
Regulated Product(s)
Dietary Supplements
Food & Beverages