tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Opgal Optronic Industries Ltd.
MARCS-CMS 613562 —
July 20, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Eran Bluestein
Recipient Title
Director of Business Development
Opgal Optronic Industries Ltd.
PO Box 462, Industrial Area 5
Karmiel
2161401
Israel
eran.b@opgal.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Eran Bluestein:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613562, dated March 4, 2021). Based on our evaluation, it appears that you have 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 in the future.
Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
07/25/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Oregon’s Wild Harvest, Inc.
MARCS-CMS 621842 —
April 19, 2023
Delivery Method:
Overnight Delivery
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Mark J. Vieceli
Recipient Title
Chief Executive Officer
Oregon’s Wild Harvest, Inc.
1601 NE Hemlock Avenue
Redmond
,
OR
97756
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
Dear Mr. Vieceli:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 621842, dated July 8, 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/
Miriam R. Burbach
Program Division Director
Content current as of:
04/19/2023
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Performance Nutrition Formulators LLC dba VMI Sports
MARCS-CMS 543959 —
February 09, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Thomas M. Reilly, Mr. Frank Fenimore Jr.
Recipient Title
President/Partner, CEO/ Partner
Performance Nutrition Formulators LLC dba VMI Sports
100 Tec Street Unit B
Hicksville
,
NY
11801
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Reilly and Mr. Fenimore Jr.:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 543959, issued on May 18, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Lillian Aveta
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
02/09/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Pet Center Inc.
MARCS-CMS 621716 —
March 06, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Animal & Veterinary
Recipient:
Recipient Name
Philip Mizrahie
Recipient Title
President
Pet Center Inc.
4105 W. Jefferson Blvd.
Los Angeles
,
CA
90016-4124
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Mr. Mizrahie:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter #621716 dated February 28, 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/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations West Division 5
Content current as of:
03/23/2023
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Pfizer Healthcare India Private Limited
MARCS-CMS 594972 —
February 08, 2023
Reference #:
FEI 3008316085
Product:
Drugs
Recipient:
Recipient Name
Mr. Albert Bourla
Recipient Title
Chairman and Chief Executive Officer
Pfizer Healthcare India Private Limited
Pfizer, Inc.
235 East 42nd Street
New York
,
NY
10017-5703
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Bourla:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-31 dated March 25, 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 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/
Matthew R Dionne
Compliance Officer
Division of Drug Quality II
CC:
Mr. Vikram Shukla, Site Leader
Pfizer Healthcare India Private Limited
Plots 116-117-118-119-111-123 (part)
Jawaharlal Nehru Pharma City, Parawada
Visakhapatnam, Andhra Pradesh, 531 019
India
Content current as of:
02/10/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
MARCS-CMS 576934 —
March 16, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Jonathan Chapman
Recipient Title
President and Chief Financial Officer
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
4600 Anson Blvd
Whitestown
,
IN
46075
United States
Issuing Office:
Division of Medical Device and Radiological Health Operations East
United States
Dear Mr. Chapman:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS# 576934, dated July 31, 2019 for your firm’s Indianapolis, IN location. 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/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Devices & Radiological Health Division One - East
Content current as of:
03/23/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Premier Nutra Pharma Inc.
MARCS-CMS 640210 —
October 11, 2023
Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Israel Kravzov
Recipient Title
Co-Chief Executive Officer
Premier Nutra Pharma Inc.
5800 Newton Drive
Carlsbad
,
CA
92008
United States
ikravzov@premiernutrapharma.com
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Mr. Kravzov:
The U.S. Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [Case # 640210; dated December 9, 2022]. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
cc: Hector Gudino
Co-Chief Executive Officer
Premier Nutra Pharma Inc.
hector@premiernutrapharma.com
Content current as of:
10/18/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Procter & Gamble Manufactura S. de R.L. de C.V.
MARCS-CMS 650837 —
March 27, 2023
Product:
Drugs
Recipient:
Recipient Name
Maria Petry
Procter & Gamble Manufactura S. de R.L. de C.V.
8700 Mason-Montgomery Road
Mason
,
OH
45040-9462
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Ms. Petrey:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2496. Based on our evaluation, you have discontinued the product listing by adding an end marketing date to the drug listing data thus the warning letter is closed. 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 assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. If this product is reintroduced in U.S. commercial distribution, FDA expects that all previous errors are corrected. 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/
Tina Smith
Acting Director,
Office of Unapproved Drugs & Labeling Compliance
Center for Drug Evaluation and Research
Office of Compliance
U.S. Food and Drug Administration
Content current as of:
03/31/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Professional Compounding Centers of America dba PCCA
MARCS-CMS 597638 —
November 21, 2023
Product:
Drugs
Recipient:
Recipient Name
Mr. Fabian V. Zaccardo
Recipient Title
Chief Operating Officer
Professional Compounding Centers of America dba PCCA
9901 S. Wilcrest Dr.
Houston
,
TX
77099-5132
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Zaccardo:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-21-15 dated January 27, 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 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/
Carla Norris
Compliance Officer
Division of Drug Quality II
Content current as of:
12/01/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Ragin Vapors
MARCS-CMS 641871 —
December 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2200673
Product:
Tobacco
Recipient:
Recipient Name
John Corey Buhler
Ragin Vapors
United States
Corey@raginvapors.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear John Corey Buhler:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has completed its evaluation of your corrective actions in response to FDA’s October 20, 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:
09/16/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Riedstra Dairy, Ltd.
MARCS-CMS 621812 —
May 24, 2023
Delivery Method:
VIA Electronic Mail
Product:
Animal & Veterinary
Recipient:
Recipient Name
Al Riedstra
Recipient Title
Owner
Riedstra Dairy, Ltd.
55985 Frank Jones Road
Mendon
,
MI
49072
United States
riedstradairy@gmail.com
Issuing Office:
Office of Human and Animal Food Operations East Division 6
United States
Dear Mr. Riedstra:
The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY22-HAFE6-04, issued on 2/4/2022. 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/
Kelli Wilkinson LCDR
Director of Compliance
Office of Human and Food Operations
Division East 6
CC:
Dr. Brandon D. Yoder, DVM
Dairy Veterinary and Management Services
2314 Eisenhower Dr N
Goshen, IN 46526
Brandon.d.yoder@gmail.com
Content current as of:
05/31/2023
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Rock Drummer Vapors LLC
MARCS-CMS 638918 —
December 07, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
ER2200622
Product:
Tobacco
Recipient:
Recipient Name
James Edward Gatewood
Rock Drummer Vapors LLC
United States
Wingrider_y2k@yahoo.com
Issuing Office:
Center for Tobacco Products
United States
Secondary Issuing Offices
United States
Dear James Edward Gatewood:
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 August 22, 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:
09/17/2024
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Rosebud's Ranch and Garden, LLC
MARCS-CMS 628567 —
March 31, 2023
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Amber R. Stephenson
Recipient Title
Owner
Rosebud's Ranch and Garden, LLC
122 W High St.
Piqua
,
OH
45356
United States
info@rosebudsrealfood.com
Issuing Office:
Division of Human and Animal Food Operations East V
United States
Dear Ms. Stephenson:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter 628567, dated October 18, 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 or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Christopher N. Dedeaux
Compliance Officer
Office of Human and Animal Foods Operations
Division 5 East
Content current as of:
04/07/2023
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Russ Davis Wholesale, Inc.
MARCS-CMS 628195 —
July 13, 2023
Product:
Food & Beverages
Recipient:
Recipient Name
Adam Gamble
Recipient Title
President and Chief Executive Officer
Russ Davis Wholesale, Inc.
266 NE Fourth Street
Wadena
,
MN
56482
United States
Issuing Office:
Office of Human and Animal Food Operations - West Division 1
United States
Dear Mr. Gamble:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 628195 dated April 28, 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/
Carolyn A. Warren
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
07/21/2023
Regulated Product(s)
Food & Beverages