tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
PETNET Solutions Inc.
MARCS-CMS 584016 —
May 17, 2022
Product:
Drugs
Recipient:
Recipient Name
Mr. Barry Scott
Recipient Title
Chief Executive Officer
PETNET Solutions Inc.
810 Innovation Drive
Knoxville
,
TN
37932
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Dear Mr. Scott:
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 #584016], dated October 17, 2019. 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
Acting Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District
Cc:
Mr. Michael Nazerias
Vice President, Regulatory Affairs & Quality Assurance
PETNET Solutions, Inc.
810 Innovation Drive
Knoxville, TN 37932
michael.nazerias@petnetsolutions.com
Ms. Jessica Burger
Facility Site Manager
PETNET Solutions Inc.
350 Washington St. Unit 268
Woburn, MA 01801
jessica.burger@petnetsolutions.com
Content current as of:
05/24/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Pharmaganics LLC
MARCS-CMS 614576 —
January 12, 2022
Product:
Dietary Supplements
Recipient:
Recipient Name
Tom Redmond III
Recipient Title
CEO
Pharmaganics LLC
8475 Parley Lake Rd
Waconia
,
MN
55387
United States
info@diabetesdoctor.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Redmond:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #614576, 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:
12/18/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Pharmcore Inc. dba Hallandale Pharmacy
MARCS-CMS 605569 —
May 03, 2022
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
David G. Rabbani
Recipient Title
Owner and President
Pharmcore Inc. dba Hallandale Pharmacy
2666 SW 36th St
Fort Lauderdale
,
FL
33312-5005
United States
drabbani@hallandalerx.com
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
Dear Mr. Rabbani :
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 #605569), issued on March 11, 2020. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Caroline Le, PharmD.
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
cc:
VIA E-MAIL
Ms. Leilani Bellieni, QA Director
Pharmcore, Inc. dba Hallandale Pharmacy
2666 Southwest 36th Street
Fort Lauderdale, Florida 33312
leilani@hallandalerx.com
Content current as of:
05/09/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Picket Fence Creamery LLC
MARCS-CMS 618726 —
July 15, 2022
Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
Jeffrey S. Burkhart and Jill L. Burkhart
Recipient Title
Co-Owners
Picket Fence Creamery LLC
14583 S. Avenue
Woodward
,
IA
50276
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
Dear Mr. and Ms. Burkhart,
The Food and Drug Administration has completed an evaluation of Picket Fence Creamery LLC corrective actions in response to our Warning Letter (CMS case #: 618726) on January 14, 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/
Matthew R. Sleeter
Acting Program Division Director
Office of Human and Animal Food
West Division II
Content current as of:
07/18/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Port Clyde Fresh Catch, Inc.
MARCS-CMS 581353 —
March 10, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Glen A. Libby
Recipient Title
President
Port Clyde Fresh Catch, Inc.
6 Culver Rd.
Port Clyde
,
ME
04855
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Dear Mr. Libby:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 581353, issued on July 15, 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/
Timothy M. Glod
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
03/14/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Prescription Dispensing Laboratories Inc.
MARCS-CMS 579286 —
February 18, 2022
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Raymond L. Solano
Recipient Title
President
Prescription Dispensing Laboratories Inc.
101 Commercial Parkway
Cedar Park
,
TX
78613
United States
Rsolano@pdlabs.net
Issuing Office:
Division of Pharmaceutical Quality Operations II
United States
Mr. Solano:
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 # 579286; Dated: July 30, 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.
If you have questions regarding the contents of this letter, you may contact John Diehl via phone at 214-253-5288 or email at john.diehl@fda.hhs.gov.
Sincerely,
/S/
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II
Content current as of:
02/25/2022
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Primus Corporation dba Trinity Biotech
MARCS-CMS 607698 —
December 22, 2022
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Ronan O'Caoimh
Recipient Title
President/CEO
Primus Corporation dba Trinity Biotech
Southern Cross Business Park
I D A Boghall Road
Bray
Co. Wicklow
Ireland
ronan.ocaoimh@trinitybiotech.com
josh.wcarsC_i,Arinitybiotech.com
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. O'Caoimh:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter (CMS # 607698) issued on August 11, 2020. Based, on our evaluation, it appears that you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Melissa Michurski,
Director Compliance Branch
Office of Medical Device and Radiological Health Division 2
Content current as of:
04/17/2024
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Purina Animal Nutrition LLC
MARCS-CMS 622828 —
September 15, 2022
Delivery Method:
VIA UPS and Electronic Mail
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mr. Rick Duncan
Recipient Title
Plant Manager
Purina Animal Nutrition LLC
100 Danforth Dr
Gray Summit
,
MO
63039
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Dear Rick Duncan:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS Case # 622828) issued on March 8, 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/
Dana Lewis
Compliance Officer
Office of Human and Animal Food-West Div. 3
Content current as of:
09/20/2022
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
QLRAD Netherlands
MARCS-CMS 510526 —
November 16, 2022
Product:
Medical Devices
Recipient:
Recipient Name
Arjen Winkel
Recipient Title
President and CEO
QLRAD Netherlands
HOSPIMED
Rietveldstraat 22
Zwolle
8013RW
Overijssel
Netherlands
awinkel@qlrad.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Winkel,
The Food and Drug Administration has completed an evaluation of QLRAD’s corrective actions in response to our Warning Letter (CMS #510526, dated July 20, 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 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/
Robert Ochs, PhD
Director
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Cc:
EA Winkel
QLRAD Inc.
HYH 9107 NW 105th Way
Medley, Florida 33178
Content current as of:
11/18/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Radhanite, LLC d/b/a Curalife Ltd
MARCS-CMS 614542 —
March 18, 2022
Product:
Dietary Supplements
Recipient:
Recipient Name
Ron Elul
Recipient Title
CEO
Radhanite, LLC d/b/a Curalife Ltd
208 Paterson Plank Rd.
Union City
,
NJ
07087
United States
https://curalife.com/
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Elul:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #614542, 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:
03/23/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Raw Juicery, Inc.
MARCS-CMS 598594 —
January 06, 2022
Delivery Method:
United States Postal Service
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Ryan O. Davidson
Recipient Title
Owner and President
Raw Juicery, Inc.
915 Mateo St.
Ste 207
Los Angeles
,
CA
90021-1786
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
Dear Mr. Davidson:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #598594 dated June 11, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
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:
01/14/2022
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
reBreathe Vapor Products
MARCS-CMS 617043 —
May 27, 2022
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101626
Product:
Tobacco
Recipient:
Recipient Name
Debbra Warren
reBreathe Vapor Products
United States
(b)(6)
Issuing Office:
Center for Tobacco Products
United States
Dear Debbra Warren:
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 29, 2021 in response to our Warning Letter dated August 20, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://rebreathevapor.com.
However, our surveillance shows you continue to offer for sale to customers in the United States other tobacco products that may be subject to market authorization requirements. FDA encourages you to discuss with your suppliers the current status of any particular tobacco product’s marketing application or any product’s marketing authorization. For additional information regarding currently marketed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement, please visit our website https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-lists?utm_medium=email&utm_source=govdelivery#list%20of%20deemed.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation of the FD&C Act, 21 U.S.C.§ 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Plush n’ Rich, LLC
Attn: Aaron Jasper
aaronjasper20@gmail.com
GoDaddy.com, LLC
abuse@godaddy.com
Content current as of:
06/02/2022
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Ricker Hill Farms, Inc.
MARCS-CMS 541362 —
May 05, 2022
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Andrew Ricker
Recipient Title
President/Manager
Ricker Hill Farms, Inc.
11 Ricker Hill Road
Turner
,
ME
04282
United States
theskibum2003@yahoo.com
Issuing Office:
New York District Office
United States
Dear Mr. Ricker:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 541362, issued on February 15, 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/
Scott Loughan
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
05/23/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Rite Aid Corporation
MARCS-CMS 643207 —
December 20, 2022
Reference #:
WL 2277
Product:
Drugs
Recipient:
Recipient Name
Elizabeth Hanlon
Rite Aid Corporation
200 Newberry Commons
Etters
,
PA
17319
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Ms. Hanlon:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2277. 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 list of active ingredients and an updated labeler code request SPL with the updated 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
Sabra Dipping Company, LLC
MARCS-CMS 615938 —
September 19, 2022
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Joseph Johnston
Recipient Title
EVP, Supply Chain
Sabra Dipping Company, LLC
15900 Sabra Way
Colonial Heights
,
VA
23834
United States
jjohnston@sabra.com
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Dear Mr. Johnston,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 615938, dated December 1, 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.
Jessica D. Weber
/S/
Compliance Officer
Baltimore District Office Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
09/20/2022
Regulated Product(s)
Food & Beverages