tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Grimann S.A. de C.V.
MARCS-CMS 632272 —
June 03, 2022
Reference #:
WL #2257
Product:
Drugs
Recipient:
Recipient Name
Esther Gonzalez
Grimann S.A. de C.V.
Circuito Nemesio Diez Riega No. 11
Lerma (P. Industrial El Cerrillo II)
52250
Lerma
,
Mexico
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Ms. Gonzalez:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #2257. Based on our evaluation, it appears that you have included a marketing end date of May 23, 2022, indicating that the product will no longer be available in U.S. commercial distribution, but you have not taken corrective measures to address the listing deficiencies. Although the Warning Letter #2257 is closed since the drug listing is discontinued, a compliance case against the data will remain open to prevent relisting since the corrective measures were not taken in this revision to address the listing deficiencies. Future FDA regulatory activities will further assess the adequacy and sustainability of these actions.
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 requirements. The Agency expects you and your firm to continue to monitor your state of compliance and maintain compliance. This letter will not preclude any future regulatory action should violations be observed during additional data review projects, future inspections, or through other means.
Sincerely,
/S/
Carolyn E. Becker, J.D.
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:
06/24/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Hand Biomechanics Lab, Inc.
MARCS-CMS 534495 —
September 07, 2022
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Dr. John M. Agee, M.D.
Recipient Title
President
Hand Biomechanics Lab, Inc.
77 Scripps Drive
Sacramento
,
CA
95825
United States
kasutton@handbiolab.com
ddequine@handbiolab.com
Issuing Office:
Los Angeles District Office
United States
Dear Dr. Agee,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to a Warning Letter dated 11/16/2017. 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 Device and Radiological Health Operations
Division 3/West
Content current as of:
09/09/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Hanlim Pharm Co., Ltd.
MARCS-CMS 553021 —
August 25, 2022
Product:
Drugs
Recipient:
Recipient Name
Mr. Daniel SC Park
Recipient Title
Plant Manager
Hanlim Pharm Co., Ltd.
2-27, Yeongmun-ro
Cheoin-gu
Yongin-si
Gyeonggi-do
17040
South Korea
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Mr. Park:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-19-01 dated October 3, 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 or 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/
Rokhsana Safaai-Jazi
Compliance Officer
Division of Drug Quality II
Content current as of:
03/14/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Hanover Foods Corporation
MARCS-CMS 612551 —
July 21, 2022
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Jeffrey Warehime
Recipient Title
CEO
Hanover Foods Corporation
1486 York Street
Hanover
,
PA
17331
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Dear Mr. Warehime,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 612551, dated March 26, 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.
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:
08/17/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy
MARCS-CMS 611130 —
June 27, 2022
Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs
Recipient:
Recipient Name
Clayton McGhan, MHA
Recipient Title
Interim West Hawaii Regional CEO
Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy
79-1019 Kaukapila Street
Kealakekua
,
HI
96750
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Mr. McGhan:
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 #611130 dated February 23, 2021. 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:
07/14/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Hetero Labs Limited Unit V
MARCS-CMS 520359 —
November 29, 2022
Reference #:
3008307735
Product:
Drugs
Recipient:
Recipient Name
Mr. P. R. Bhaskar Reddy
Recipient Title
Vice President – Operations
Hetero Labs Limited Unit V
Surv. No. 439-441, 458
Polepally Village, Jadcherla Mandal
Mahaboob Nagar
509301
Telangana
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 320-17-46 dated August 15, 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 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/
Jason F. Chancey
Consumer Safety Officer
Division of Drug Quality I
Content current as of:
12/02/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
High Voltage Vaporz LLC
MARCS-CMS 614672 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101592
Product:
Tobacco
Recipient:
Recipient Name
Brad Ridenour and Malinda Ridenour
High Voltage Vaporz LLC
United States
highvoltagevape@gmail.com
(b)(6)
Issuing Office:
Center for Tobacco Products
United States
Dear Brad Ridenour and Malinda Ridenour:
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 24, 2021 and October 4, 2021, to our Warning Letter dated May 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://highvoltagevaporz.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
HIGHVOLTAGEVAPORZ.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
06/03/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Highbrow Vapor
MARCS-CMS 616873 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101623
Product:
Tobacco
Recipient:
Recipient Name
Bryan Peck
Highbrow Vapor
United States
bryan@highbrowvapor.com
Issuing Office:
Center for Tobacco Products
United States
Dear Bryan Peck:
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 August 23, 2021 to our Warning Letter dated August 13, 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://highbrowvapor.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
highbrowvapor.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
06/08/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Holistic Healer & Wellness Center, Inc.
MARCS-CMS 614538 —
March 15, 2022
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Stacy Sanchez
Holistic Healer & Wellness Center, Inc.
3998 Clippert St.
P.O. Box 23017
Dearborn
,
MI
48123
United States
sales@holistichealeronline.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Ms. Sanchez:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #614538, 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:
03/21/2022
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Honey Feast, Inc.
MARCS-CMS 621651 —
July 08, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
22-HAFE4-WL-04
Product:
Dietary Supplements
Recipient:
Recipient Name
Charles E. Sanford
Recipient Title
Owner
Honey Feast, Inc.
6906 Lake Nellie Rd.
Clermont
,
FL
34714-8368
United States
charlie@honeyfeast.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV
United States
Dear Mr. Sanford:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 22-HAFE4-WL-04 dated March 17, 2022. 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:
07/15/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Hoya Corporation - Pentax Life Division
MARCS-CMS 546991 —
April 04, 2022
Product:
Medical Devices
Recipient:
Recipient Name
Ojas A. Buch
Recipient Title
President
Hoya Corporation - Pentax Life Division
PENTAX Medical - Americas
3 Paragon Drive
Montvale
,
NJ
07645
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Ojas A. Buch:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 546991, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) 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.
Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Center for Devices and Radiological Health
CC:
William Goeller
Vice President, Quality Assurance and Regulatory Affairs
Pentax Medical- A Division of Pentax of America, Inc.
3 Paragon Drive
Montvale, New Jersey 07645
Mr. Hiroshi Suzuki
President and CEO
Hoya Corporation (PENTAX Life Care Division)
Showanomori Technology Center
1-1-110 Tsutsujigaoka, Akishima-shi
Tokyo 196-0012
Japan
Content current as of:
04/08/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Illumivaption, Inc.
MARCS-CMS 618819 —
July 01, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101646
Product:
Tobacco
Recipient:
Recipient Name
David Pellicane
Illumivaption, Inc.
United States
david@nashvillevapor.com
orders@nashvillevapor.com
Issuing Office:
Center for Tobacco Products
United States
Dear David Pellicane:
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 October 12, 2021 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.nashvillevapor.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
Nashvillevapor.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Robert Preston Warfield
preston@nashvillevapor.com
Content current as of:
07/14/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Induction Therapies, LLC
MARCS-CMS 616487 —
October 31, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Angelia L. Inscoe
Recipient Title
Chief Executive Officer
Induction Therapies, LLC
1920 Stanley Gault Pkwy
Suite 100
Louisville
,
KY
40223
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Ms. Inscoe:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, CMS# 616487, dated November 23, 2021 for your firm’s Louisville, KY location. 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/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Devices & Radiological Health Division One - East
Content current as of:
11/08/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Infusion Partners, LLC
MARCS-CMS 575451 —
January 26, 2022
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Michael A. Curtis
Recipient Title
Senior Manager of Operations
Infusion Partners, LLC
4137 Boardman Canfield Rd
Ste L104
Canfield
,
OH
44406-8087
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
Dear Mr. Curtis:
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 # 575451; dated March 20, 2019]. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Nicholas F. Lyons
Director of Compliance
Office of Pharmaceutical Quality Operations, Division III
Content current as of:
02/11/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Innova Medical Group, Inc.
MARCS-CMS 614819 —
October 21, 2022
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Robert “Bobby” A. Kasprzak
Recipient Title
Chief Executive Officer
Innova Medical Group, Inc.
800 E. Colorado Blvd.
Suite 288
Pasadena
,
CA
91101
United States
rak@innovamedgroup.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Kasprzak:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #614819) dated June 10, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter for your manufacturing facilities located at 800 E. Colorado Blvd., Suite 288, Pasadena, CA; 495 N. Berry St., Brea, CA (Out of Business); and MPS Medical, Inc. at 785 Challenger St., Brea, CA. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other
relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be
observed during a subsequent inspection or through other means.
Sincerely,
/S/
Jessica Mu
Director, Compliance Branch
Office of Medical Device and Radiological Health Operations
Division 3
Cc: Douglas W. Woodruff, Chief Regulatory, Quality, and Clinical Affairs Officer, Innova Medical Group,
Inc. Douglas.Woodruff@innovamedgroup.com
Morris L. Young, Vice President of Quality, Innova Medical Group, Inc.
Morris.Young@innovamedgroup.com
Content current as of:
10/25/2022
Regulated Product(s)
Medical Devices