tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Zydus Lifesciences Limited
MARCS-CMS 584856 —
November 03, 2022
Reference #:
3002984011
Product:
Drugs
Recipient:
Recipient Name
Dr. Shavril Patel
Recipient Title
Managing Director
Zydus Lifesciences Limited
Cadila Healthcare Limited
Khoraj (Gandhinagar)
Nr. Vaishmodevi Circle
Ahmedabad
382481
Gujarat
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Dr. Patel:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-05 dated October 29, 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/
for
Rebecca Parrilla
Compliance Officer
Division of Drug Quality I
Content current as of:
11/28/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Adore eLiquid
MARCS-CMS 613523 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101518
Product:
Tobacco
Recipient:
Recipient Name
Dawn Carrillo
Adore eLiquid
United States
info@adoreeliquid.com
adoreeliquid@gmail.com
adoreeliquid@icloud.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Dawn Carrillo:
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 February 26, 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
VIA Electronic Mail
cc:
Domains By Proxy, LLC
ADOREELIQUID.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
09/09/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Alchymars ICM SM Private Limited
MARCS-CMS 542879 —
January 31, 2023
Reference #:
FEI 3005216842
Product:
Drugs
Recipient:
Recipient Name
Mr. K. Nagaradjan
Recipient Title
General Manager and Director
Alchymars ICM SM Private Limited
A-14 & 20 SIDCO Pharmaceutical Complex
Alathur, Chengalpattu District
603110
Tamil Nadu
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Nagaradjan:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-18-35 dated February 16, 2018.
Based on our evaluation, it appears that you have addressed the deviations 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 deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Marisa Heayn
Compliance Officer
Division of Drug Quality II
Content current as of:
02/03/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Auro Pharmacies, Inc.
MARCS-CMS 608369 —
April 11, 2023
Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs
Recipient:
Recipient Name
Dr. Nayan Patel
Recipient Title
CEO
Auro Pharmacies, Inc.
520 W La Habra Blvd.
La Habra
,
CA
90631
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Dr. Patel:
The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letters (WL 8-17 dated December 13, 2016, and WL CMS 608369 dated June 3, 2020). 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 the warning letters.
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:
04/14/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Aurobindo Pharma Limited
MARCS-CMS 577033 —
February 09, 2023
Reference #:
FEI 3004611182
Product:
Drugs
Recipient:
Recipient Name
Mr. K. Nithyananda Reddy
Recipient Title
Managing Director
Aurobindo Pharma Limited
Sy. No. 61-66, IDA, Pydibhimavaram, Ranasthalam (Mandal)
Srikakulam District
532409
Andhra Pradesh
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Reddy:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-27 dated June 20, 2019.
Based on our evaluation, it appears that you have addressed the deviations 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 deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Tamara Rosbury, Ph.D.
Compliance Officer
Division of Drug Quality II
Content current as of:
02/10/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Banks Square Market Corp dba The Produce Connection
MARCS-CMS 631118 —
April 18, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Frank Rossetti
Recipient Title
President/Owner
Banks Square Market Corp dba The Produce Connection
96 Audubon Road
Wakefield
,
ME
01880
United States
Issuing Office:
Office of Human and Animal Food Operations - East Division 1
United States
Dear Mr. Rossetti:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 631118, issued on September 2, 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/
Latoya Griffith
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
04/24/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
BioModeling Solutions, Inc.
MARCS-CMS 540821 —
January 31, 2023
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Kirk Huntsman
Recipient Title
CEO
BioModeling Solutions, Inc.
Vivos Therapeutics, Inc.
7921 Southpark Plaza, Ste. 210
Littleton
,
CO
80120
United States
kirk@vivoslife.com
Issuing Office:
Los Angeles District Office
United States
Dear Mr. Huntsman,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to Warning Letter #540821-18 dated 1/12/2018. 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
Compliance Branch Director
Office of Medical Devices and Radiological Health Operations
Division 3/West
Cc: Kim Griffith, Director of Compliance, kgriffith@vivoslife.com / Marc Sanchez, Counsel, msanchez@fdaatty.com
Content current as of:
02/03/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Brad Grate Dairy Farm
MARCS-CMS 631036 —
July 24, 2023
Delivery Method:
VIA Electronic Mail
Product:
Animal & Veterinary
Recipient:
Recipient Name
Brad R. Grate
Recipient Title
Owner
Brad Grate Dairy Farm
3035 Country Road 14
Waterloo
,
IN
46793
United States
Grateproperties@gmail.com
Issuing Office:
Office of Human and Animal Food Operations East Division 6
United States
Dear Mr. Grate:
The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY22-HAFE6-07, issued on 6/24/2022. 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 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/
CDR Kelli L. Wilkinson
Director of Compliance
Office of Human and Food Operations
Division East 6
CC:
Dr. David J. Hargarten, DVM
Auburn Hills Animal Hospital
3120 Country Rd. 36
Auburn, IN 46706
auburnhills.vets@gmail.com
Content current as of:
07/27/2023
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Brigham and Women’s Hospital Inc.
MARCS-CMS 623476 —
May 24, 2023
Delivery Method:
Via Electronic Mail - Delivery and Read Receipt Requested
Product:
Drugs
Recipient:
Recipient Name
Dr. Robert Higgins
Recipient Title
President and CEO
Brigham and Women’s Hospital Inc.
15 Francis Street
Boston
,
MA
02115-6110
United States
rhiggins4@bwh.harvard.edu
Issuing Office:
Office of Pharmaceutical Quality Operations Division I
United States
Dear Dr. Higgins:
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 # 623476], dated April 11, 2022. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Respectfully,
/S/
Lisa Harlan
Program Division Director
U.S. Food and Drug Administration
Office of Pharmaceutical Operations,
Division I
CC:
Dr. Jonathan Barlow
Director Nuclear Pharmacy Services and BICOR
Brigham and Women’s Hospital Inc.
75 Francis Street
Boston, MA.02115-6110
Email: jkbarlow@bwh.harvard.edu
Content current as of:
05/31/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Buku Vapor LLC
MARCS-CMS 623498 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2100397
Product:
Tobacco
Recipient:
Recipient Name
Daniel Borel
Buku Vapor LLC
United States
bukuvapor@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear Daniel Borel:
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 January 12, 2022 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:
09/09/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
ByPro Nutrition, LLC
MARCS-CMS 646308 —
November 30, 2023
Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Robert L Bynum
Recipient Title
Owner
ByPro Nutrition, LLC
1906 Potomac Dr
Columbia
,
MO
65203-5843
United States
dr.bynum@bypronutrition.com
Issuing Office:
Division of Human and Animal Food Operations West II
United States
Dear Mr. Bynum:
The Food and Drug Administration has completed an evaluation of ByPro Nutrition, LLC corrective actions in response to our Warning Letter (CMS case #: 646308) on April 4, 2023. 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/
LaTonya M. Mitchell, Ph.D.
Program Division Director,
Office of Human and Animal Food Operations,
West Division II
Content current as of:
12/05/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Cafe Valley Bakery, LLC
MARCS-CMS 603875 —
November 07, 2023
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Brian Owens
Recipient Title
CEO
Cafe Valley Bakery, LLC
7000 W. Buckeye Road
Phoenix
,
AZ
85043
United States
bowens@cafevalley.com
Issuing Office:
Office of Human & Animal Food Operations East 6
United States
Dear Mr. Owens:
The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY2020-HAFE6-02, issued on 03/18/2020. 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 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/
CDR Kelli L. Wilkinson
Director of Compliance
Office of Human and Food Operations
Division East 6
Content current as of:
11/14/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Calroy Health Sciences, LLC
MARCS-CMS 636311 —
July 19, 2023
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Chen and Mr. Hoyt
Calroy Health Sciences, LLC
14362 N Frank Lloyd Wright
Suite 1000
Scottsdale
,
AZ
85260
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Chen and Mr. Hoyt:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #636311, issued November 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/
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:
07/21/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Calvin Scott & Company, Inc.
MARCS-CMS 606987 —
August 04, 2023
Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Jan-Erik Palm
Recipient Title
President
Calvin Scott & Company, Inc.
209 Eubank Blvd NE
Albuquerque
,
NM
87123
United States
jepalm@calvinscottinc.com
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Mr. Palm:
The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL #606987) dated August 25, 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 the 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:
08/10/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Cangene BioPharma, LLC
MARCS-CMS 630316 —
October 04, 2023
Delivery Method:
ELECTRONIC DELIVERY/READ RECEIPT
Product:
Drugs
Recipient:
Recipient Name
Mr. David Fidler
Recipient Title
Vice President, Manufacturing Operations, General Manager
Cangene BioPharma, LLC
1111 S. Paca St.
Baltimore
,
MD
21230
United States
fidlerd@ebsi.com
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Dear Mr. Fidler:
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 #630316], dated August 10, 2022. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Respectfully,
/S/
Lisa Harlan
Program Division Director
U.S. Food and Drug Administration
Office of Pharmaceutical Quality Operations Division I
Content current as of:
10/04/2023
Regulated Product(s)
Drugs