tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
UCC Ueshima Coffee Company Inc. - America
MARCS-CMS 612006 —
March 23, 2022
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Jay S. Egami
Recipient Title
President
UCC Ueshima Coffee Company Inc. - America
723a Liggett Avenue
San Francisco
,
CA
94129-1480
United States
jay@ucc-america.com
Issuing Office:
Division of West Coast Imports
United States
Dear Mr. Jay S. Egami:
The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated January 29, 2021 (CMS #612006). 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/
Lawton W. Lum
Compliance Branch Director
Division of West Coast Imports
Content current as of:
04/01/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Unit Dose Services, LLC
MARCS-CMS 636177 —
December 21, 2022
Reference #:
WL 2310
Product:
Drugs
Recipient:
Recipient Name
Peter Levasseur
Unit Dose Services, LLC
20201 Northeast 16th Place
Miami
,
FL
33179
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Levasseur:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2310. Based on our evaluation, it appears that you have addressed the violations contained in this warning letter and corrected the data deficiencies. We have received an updated listing SPL with the correct carton label image for your product and an updated labeler code request SPL with the new contact information. 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 ensure 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 a subsequent inspection or through other means.
Sincerely,
/S/
Carolyn E. Becker, JD
Director, Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Content current as of:
12/27/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Vaccaro's Italian Pastry Shop, Inc.
MARCS-CMS 577001 —
January 04, 2022
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Maria R. Vaccaro
Recipient Title
Vice President
Vaccaro's Italian Pastry Shop, Inc.
3705 E. Baltimore Street
Baltimore
,
MD
21224-1509
United States
cookies@vaccarospastry.com
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Dear Ms. Vaccaro,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 577001, dated March 24, 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/
Jessica D. Weber
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
Cc (via email):
Randy F. Pack, Program Division Director, District Director (randy.pack@fda.hhs.gov)
William Murray, State Liaison (william.murray@fda.hhs.gov)
Robin M. Rivers, Director, Compliance Branch (robin.rivers@fda.hhs.gov)
Martin J. Guardia, Director, Investigations Branch (martin.guardia@fda.hhs.gov)
Cornelius Brown III, Supervisory Consumer Safety Officer (cornelius.brown1@fda.hhs.gov)
Content current as of:
01/14/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Valley Biosystems
MARCS-CMS 632553 —
October 14, 2022
Product:
Biologics
Recipient:
Recipient Name
Steve Cello
Recipient Title
Site Director
Valley Biosystems
1265 Triangle Court
West Sacramento
,
CA
95605
United States
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
Dear Mr. Cello:
The United States Food and Drug Administration (FDA) acknowledges receipt of your letter dated August 24, 2022, responding to the Warning Letter (WL) issued by FDA on August 3, 2022, to Valley Biosystems Inc. (VBS). The WL pertained to the firm’s conduct involving Good Laboratory Practice (GLP) nonclinical studies S18-10688 and S19-10708.
We reviewed your response stating that VBS developed a post-inspection action plan to remediate the inspectional findings and that VBS was acquired by Altasciences USA LLC (Altasciences). We acknowledge your firm’s commitment to no longer perform FDA regulated GLP nonclinical studies under 21 CFR Part 58, and note that VBS and Altasciences have taken steps to cease conducting such GLP studies for the VBS clients.
Your action has resolved the remaining issues described in the August 3, 2022, Warning Letter.
Sincerely,
/S/
Melissa J. Mendoza, JD
Acting Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
cc:
Eric Pittman, Director
FDA ORA-BIMO West
Content current as of:
10/18/2022
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Vapor Candy, LLC d/b/a The Vape Stop
MARCS-CMS 625949 —
July 01, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2201730
Product:
Tobacco
Recipient:
Recipient Name
Ricardo Leyba and Colleen Leyba
Vapor Candy, LLC d/b/a The Vape Stop
United States
rick@vaporcandyusa.com
info@vaporcandyusa.com
colleenleyba@gmail.com
vaporcandy@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Ricardo Leyba and Colleen Leyba:
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 January 28, 2022, February 1, 2022, and June 20, 2022, in response to our Warning Letter dated January 28, 2022. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website http://vaporcandyusa.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:
Attn: Darren Keith Corley
dcorley001@gmail.com
GoDaddy.com, LLC
abuse@godaddy.com
InMotion Hosting, Inc.
abuse@inmotionhosting.com
Content current as of:
07/14/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapor City Plus LLC
MARCS-CMS 613454 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101504
Product:
Tobacco
Recipient:
Recipient Name
Eugene Crane
Vapor City Plus LLC
United States
vaporcityplus@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Eugene Crane:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective action included in your response dated March 10, 2021 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://vaporcityplus.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:
05/27/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapor Maven E-Juice, LLC
MARCS-CMS 613453 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101503
Product:
Tobacco
Recipient:
Recipient Name
Hermin Thind
Vapor Maven E-Juice, LLC
United States
support@vmavendistribution.com
sales@vmavendistribution.com
Issuing Office:
Center for Tobacco Products
United States
Dear Hermin Thind:
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 March 13, 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://vapormaven.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:
Nailling & Terrell PLLC
Attn: Rob Terrell
rob@naillingandterrell.com
GoDaddy.com, LLC
abuse@godaddy.com
Choopa, LLC
abuse@choopa.com
Content current as of:
06/01/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vapor Springs LLC
MARCS-CMS 613744 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101540
Product:
Tobacco
Recipient:
Recipient Name
Matthew Guidry
Vapor Springs LLC
United States
admin@vapor-springs.com
support@vapor-springs.com
Issuing Office:
Center for Tobacco Products
United States
Dear Matthew Guidry:
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 April 15, 2021 in response to our Warning Letter dated March 12, 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://vapor-springs.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,
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 0149534780
vapor-springs.com@contactprivacy.com
Tucows Domains, Inc
domainabuse@tucows.com
Weebly, Inc
weebly-abuse@squareup.com
Content current as of:
06/22/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Vegas Vapor Emporium
MARCS-CMS 613745 —
July 29, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101541
Product:
Tobacco
Recipient:
Recipient Name
Michael Torsiello, Rod Rifkin, and Denise Kordelski
Vegas Vapor Emporium
United States
vegasvaporemporium@gmail.com
support@vegasvaporemporium.com
Issuing Office:
Center for Tobacco Products
United States
Dear Michael Torsiello, Rod Rifkin, and Denise Kordelski:
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 emails dated March 16, 2021, April 5, 2021, April 12, 2021, and May 6, 2021, in response to our Warning Letter dated March 12, 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.vegasvaporemporium.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 Johnson
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Network Solutions, LLC
abuse@web.com
Google LLC
Google-cloud-compliance@google.com
Content current as of:
09/14/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Visible Vapors, LLC
MARCS-CMS 616347 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101617
Product:
Tobacco
Recipient:
Recipient Name
Tracey Breuer and Daniel J. Breuer
Visible Vapors, LLC
United States
visiblevapors@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Tracy Breuer and Daniel J. Breuer:
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 August 1, 2021 and August 18, 2021 to our Warning Letter dated July 28, 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.visiblevapors.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:
DigitalOcean, LLC
abuse@digitalocean.com
GoDaddy.com, LLC
abuse@godaddy.com
Content current as of:
06/07/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Walfer Corporation dba Wallace Pharmacy
MARCS-CMS 611017 —
September 20, 2022
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Wayne Wallace
Recipient Title
Owner
Walfer Corporation dba Wallace Pharmacy
3524 B Tamiami Trail
Port Charlotte
,
FL
33952-8100
United States
Wallacepharmacy85@gmail.com
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
Dear Mr. Wallace:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS Case #611017), dated September 17, 2021. We acknowledge that your firm no longer produces sterile drug products. 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/
Mark Rivero
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
cc: Via Electronic Mail
Jonathan Meltz, Esq.
CHAPMAN LAW GROUP
1001 Brickell Bay Dr., Suite 1714
Miami, Florida 33131
JMeltz@ChapmanLawGroup.com
Content current as of:
09/26/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Wickimed Medical Equipment Manufacturing Co., Ltd.
MARCS-CMS 623042 —
May 23, 2022
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Mac Lai
Recipient Title
CEO
Wickimed Medical Equipment Manufacturing Co., Ltd.
XingWang Street, LiLin Town
ZhongKai Hi-Tech Zone
Huizhou Shi
Guangdong Sheng
,
516003
China
mac_lai@wickimed.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Lai:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 623042, dated January 7, 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 nor 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/
Cynthia Long, MD, FACS
Acting Division Director
Division of General Surgery Devices
Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
David Lennarz
Registrar Corp144
Research Drive
Hampton, VA 2366
Content current as of:
06/02/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Yippee Farms, LLC
MARCS-CMS 628623 —
December 01, 2022
Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Recipient:
Recipient Name
Arlin L. Benner
Recipient Title
Owner
Yippee Farms, LLC
1020 Pinkerton Road
Mount Joy
,
PA
17552-9242
United States
yippeefarm@gmail.com
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Dear Mr. Benner,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 628623, dated May 5, 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.
Andrew Howard
/S/
Consumer Safety Officer/Compliance Officer
Office of Human and Animal Food East II
Baltimore District Office
U.S. Food and Drug Administration
Tel: 410-779-5125
Cel: 240-506-1758
Andrew.Howard@fda.hhs.gov
Content current as of:
12/02/2022
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Zhoushan Haichang Co. Ltd
MARCS-CMS 630966 —
June 08, 2022
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jian Guo Zhou
Recipient Title
General Manager
Zhoushan Haichang Co. Ltd
Pingyang Industrial Zone
Shenjiamen
Putuo Qu
Zhoushan Shi
Zhejiang Sheng
,
316101
China
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear: Mr. Jian Guo Zhou:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 630966, issued May 9, 2022. 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:
06/10/2022
Regulated Product(s)
Food & Beverages