tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
MARCS-CMS 555295 —
April 04, 2022
Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Mr. Nasim P. Barrack
Recipient Title
Chief Consultant Pharmacist
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
41538 Eastman Dr.
STE A
Murrieta
,
CA
92562-8007
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Mr. Barrack:
The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL# 555295, dated September 19, 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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
04/19/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Innovative Sterilization Technologies LLC
MARCS-CMS 524761 —
December 27, 2022
Product:
Medical Devices
Recipient:
Recipient Name
Scott E. Cohen
Recipient Title
President / Chief Executive Officer
Innovative Sterilization Technologies LLC
7625 Paragon Road
Suite A
Dayton
,
OH
45459-4063
United States
SCohen@ISTSterilization.com
Issuing Office:
Division of Medical Device and Radiological Health Operations East
United States
Dear Mr. Cohen:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated March 20, 2019 (WL # 524761). 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/
Gina Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health,
Division 1
U.S. Food and Drug Administration
Cc: Dave Billman, COO, DBillman@ISTSterilization.com
Randy J. Prebula, randy.prebula@hoganlovells.com
Content current as of:
12/27/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Integrated Health Concepts Inc.
MARCS-CMS 610546 —
January 18, 2022
Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Taylor Cline
Recipient Title
Chief Executive Officer and President
Integrated Health Concepts Inc.
720 Aerovista Place
Suite D
San Luis Obispo
,
CA
93401-8726
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Mr. Taylor Cline:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL 610546) dated September 10, 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:
02/02/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Intrathecal Compounding Specialists, LLC
MARCS-CMS 610639 —
January 19, 2022
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Kevin Schneider
Recipient Title
Owner
Intrathecal Compounding Specialists, LLC
206A Jacob’s Run
Scott
,
LA
70583-8907
United States
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
Dear Mr. Schneider:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL 610639) dated September 15, 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/
H.L Jamillah Selby
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II
Content current as of:
02/14/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Invisi Smart Technologies UK LTD
MARCS-CMS 614512 —
February 17, 2022
Product:
Medical Devices
Recipient:
Recipient Name
Ms. Saba Yussouf
Recipient Title
CEO
Invisi Smart Technologies UK LTD
112 Cumberland House
80 Scrubs Lane
London
NW10 6RF
United Kingdom
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Ms. Yussouf:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS #614512 dated August 24, 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/
Cynthia J. Chang, Ph.D.
Director
DHT 4B: Division of Infection Control and Plastic
Surgery Devices
OHT4: Office of Office of Surgical and Infection
Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
02/23/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Legend Vapor, Inc. d/b/a Legend Vapor
MARCS-CMS 614222 —
August 12, 2022
Delivery Method:
VIA Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Donal Bush, Kelly Bush and Chris Moore
Legend Vapor, Inc. d/b/a Legend Vapor
United States
sales@legendvapor.com
Issuing Office:
Center for Tobacco Products
United States
Dear Donal Bush, Kelly Bush and Chris Moore:
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 April 26, 2021, May 6, 2021, June 23, 2021, November 8, 2021 and July 28, 2022, to our Warning Letter dated April 9, 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.legendvapor.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:
Domains By Proxy, LLC
LEGENDVAPOR.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Cloudflare, Inc.
abuse@cloudflare.com
Content current as of:
09/07/2023
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
The Lennox, International, Inc.
MARCS-CMS 606889 —
November 22, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mr. Akiva Boclin
Recipient Title
President
The Lennox, International, Inc.
100 Randolph Road
Somerset
,
NJ
08873-1384
United States
aboclin@lennoxrawhide.com
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Dear Mr. Boclin,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 606889, dated September 29, 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.
Jessica D. Weber
/S/
Compliance Officer
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
T: 410-779-5407
M: 443-280-1276
jessica.weber@fda.hhs.gov
Content current as of:
11/23/2022
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Lewiston Feed & Produce Company
MARCS-CMS 613123 —
July 08, 2022
Product:
Animal & Veterinary
Recipient:
Recipient Name
Steven R. Kanz
Recipient Title
President
Lewiston Feed & Produce Company
P.O. Box 309
Lewiston
,
MN
55952
United States
Issuing Office:
Office of Human and Animal Foods – West Division
United States
Dear Mr. Kanz:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 613123 dated September 15, 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/
Carolyn A. Warren
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
07/14/2022
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
LIV Health LLC dba INFINIWELL and DEAL Media LLC dba HARMONIA
MARCS-CMS 613114 —
May 25, 2022
Delivery Method:
Via Email
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Roger Frantz and Jeremy S. Delk
LIV Health LLC dba INFINIWELL and DEAL Media LLC dba HARMONIA
881 Corporate Drive
Lexington
,
KY
40503
United States
Jeremy.Delk@delkinc.com
Issuing Office:
Office of Human and Animal Foods Operations‐East V
United States
Dear Messrs. Frantz and Delk:
The Food and Drug Administration (FDA) completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 613114. Based on our evaluation, it appears 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/
Zada L. Giles
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East
Cc: Dustin Cappelletto, CEO via Dustin@livhealth.com
Content current as of:
07/05/2022
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
LJ's E-Smokes LLC
MARCS-CMS 614221 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101573
Product:
Tobacco
Recipient:
Recipient Name
Henry Williams
LJ's E-Smokes LLC
United States
support@ljesmokes.com
henry@ljesmokes.com
Issuing Office:
Center for Tobacco Products
United States
Dear Henry Williams:
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 April 27, 2021 and May 13, 2021 to our Warning Letter dated April 9, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website http://www.ljesmokes.com.
However, 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 authorization. For additional information regarding the marketing status of tobacco products that a company generally might manufacture, distribute, or sell, 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 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:
Contact Privacy, Inc. Customer 0146209974
ljesmokes.com@contactprivacy.com
Tucows Domains Inc.
domainabuse@tucows.com
InMotion Hosting, Inc.
abuse@inmotionhosting.com
Content current as of:
06/08/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Local Legends Distribution LLC
MARCS-CMS 618806 —
June 17, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101653
Product:
Tobacco
Recipient:
Recipient Name
Harrison Haugland
Local Legends Distribution LLC
United States
Issuing Office:
Center for Tobacco Products
United States
Dear Harrison Haugland:
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 June 16, 2022 in response to our Warning Letter dated October 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://www.locallegendsatx.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:
GoDaddy.com
abuse@godaddy.com
Wix.com
abuse@wix.com
Content current as of:
06/24/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Long Life Unlimited
MARCS-CMS 533282 —
February 17, 2022
Product:
Dietary Supplements
Recipient:
Recipient Name
Barbara A. Long
Long Life Unlimited
328 E. Kirby St.
Lima
,
OH
45804
United States
Issuing Office:
Cincinnati District Office
United States
Dear Ms. Long:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter 533282 issued on January 31, 2018. Based on our evaluation of your website: www.longlifeunlimited.com on January 31, 2022, 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 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.
/S/
Stephen J. Rabe
Compliance Officer
Content current as of:
02/25/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Lux Commercial Group LLC
MARCS-CMS 614025 —
July 06, 2022
Product:
Food & Beverages
Recipient:
Recipient Name
Rogerio Rodriguez
Recipient Title
President
Lux Commercial Group LLC
4405 S Shary Rd
Apt 624
Mission
,
TX
78572-0920
United States
Issuing Office:
Division of Southwest Imports
United States
Dear Mr. Rodriguez,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter Ref: CMS 614025 dated May 18, 2021. Based on our evaluation of the most recent follow-up inspection, 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/
Kendra J. Tunney
Compliance Officer
Division of Southwest Imports
Content current as of:
07/14/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Lysulin, Inc.
MARCS-CMS 614517 —
May 25, 2022
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
John Burd
Lysulin, Inc.
4930 Bradshaw Ct.
San Diego
,
CA
92130
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Burd:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #614517, issued September 7, 2021. 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:
06/24/2022
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Magic Vape Shop
MARCS-CMS 617030 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101627
Product:
Tobacco
Recipient:
Recipient Name
James Lettig and Joseph Lettig
Magic Vape Shop
United States
joseph365232@gmail.com
(b)(6)
Issuing Office:
Center for Tobacco Products
United States
Dear James Lettig and Joseph Lettig:
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 September 07, 2021, September 16, 2021 and September 27, 2021 in response to our Warning Letter dated August 20, 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.magicvapeshop.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:
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
06/10/2022
Regulated Product(s)
Tobacco