tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
TSDR Pharmacy Inc. dba brandMD Skin Care
MARCS-CMS 540960 —
April 29, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Cosmetics
Drugs
Recipient:
Recipient Name
Samuel D. Raoof
Recipient Title
CEO and President
TSDR Pharmacy Inc. dba brandMD Skin Care
20660 Nordhoff Street
Chatsworth
,
CA
91311-6114
United States
Issuing Office:
Center for Drug Evaluation and Research
19701 Fairchild
Irvine
,
CA
92612-2506
United States
949-608-2900
Dear Mr. Raoof:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s response to our warning letter dated November 9, 2017. We acknowledge that your California state-issued pharmacy license (PHY 50543) has been cancelled and that your facility is closed.
If you decide to resume production of drug products, FDA strongly recommends that you undertake a comprehensive assessment of your operations, and that you notify FDA prior to resuming drug production. You are expected to take all necessary steps to assure 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:
05/07/2019
Regulated Product(s)
Cosmetics
Drugs
CLOSEOUT LETTER
TSUKIJI MOTOHIKO CO., LTD.
MARCS-CMS 578659 —
October 16, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Ito Motoki
Recipient Title
President
TSUKIJI MOTOHIKO CO., LTD.
1-12-12 Minamisuna
Koto-Ku
,
Tokyo
136-0076
Japan
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Motoki:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 578659, issued May 08, 2019. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Robyn R. Jones
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/23/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Uckele Health & Nutrition, Inc.
MARCS-CMS 540533 —
October 09, 2019
Delivery Method:
VIA UPS
Reference #:
FY18-HAFE6-04
Product:
Dietary Supplements
Recipient:
Recipient Name
Michael J. Uckele
Recipient Title
CEO
Uckele Health & Nutrition, Inc.
5600 Silberhorn Highway
Blissfield
,
MI
49228
United States
Issuing Office:
Office of Human and Animal Food Division East 6
550 W. Jackson Blvd.
Suite 1500
Chicago
,
IL
60661
United States
Dear Mr. Uckele:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (FY18-HAFE6-04, dated March 6, 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/
Byron Ho, DVM
Compliance Officer
Office of Human and Animal Food
Division East 6
Content current as of:
10/10/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
U.L. Manufacturing Company Ltd.
MARCS-CMS 539712 —
April 24, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Nadine Kelly-Reid
U.L. Manufacturing Company Ltd.
418 Cedar Place
Ebony Vale
Spanish Town P.O.
St. Catherine
Jamaica
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Ms. Kelly-Reid:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #539712, issued November 16, 2017. 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/
Maria Corpuz, Supervisor
Food Adulteration Assessment Branch
Division of Enforcement
Center for Food Safety and Applied Nutrition
Content current as of:
05/07/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Unique EnCapsulation Technology LLC
MARCS-CMS 506356 —
February 08, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
K.G. Rao
Recipient Title
Founder & CEO
Unique EnCapsulation Technology LLC
9 Lenel Road
Landing
,
NJ
07850
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
6000 Metro Drive
Suite 101
Baltimore
,
MD
21215
United States
(410) 779-5455
Dear Mr. Rao,
On November 8, 2018, the Food and Drug Administration completed an evaluation of your firm’s corrective actions in response to our Warning Letter (#506356) dated January 17, 2017. Based on our evaluation of your most recent inspection that was concluded November 8, 2018, 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. If you have any questions related to this letter, I can be contacted via email at
rochelle.young@fda.hhs.gov
or by phone at 410-779-5437.
Sincerely,
/S/
CDR Rochelle B. Young, RPh. MSA
Office of Human & Animal Food East Division 2
Compliance Officer
Content current as of:
05/15/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Universal Pure, LLC
MARCS-CMS 455150 —
May 16, 2019
Delivery Method:
UPS Overnight
Reference #:
2015-DAL-WL-28
Product:
Food & Beverages
Recipient:
Recipient Name
Jeffrey L. Barnard
Recipient Title
President
Universal Pure, LLC
Universal Pasteurization, LLC
1601 Pioneers Blvd.
Lincoln
,
NE
68502
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Barnard,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (Ref: 2015-DAL-WL-28) dated August 24, 2015, issued following inspection of your facility located at 777 Freeport Pkwy, Ste. 130, Coppell, TX 75019. 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. If you choose to reestablish or sell your operations, 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 Hensley
Director of Compliance
Office of Human and Animal Food, WD3
Content current as of:
05/28/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Vilex in Tennessee, Inc
MARCS-CMS 543749 —
March 15, 2019
Recipient:
Recipient Name
Silvia J. Southard
Recipient Title
President
Vilex in Tennessee, Inc
111 Moffitt Street
McMinnville
,
TN
37110-2235
United States
Issuing Office:
Center for Devices and Radiological Health
555 Winderley Place
Suite 200
Maitland
,
FL
32751
United States
Dear Ms. Southard:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter #543749, dated January 8, 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 requirements 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/
Blake Bevill, MS
Program Division Director
Office of Medical Devices and Radiological Health Operations
OMDRHO Division 2 - Central
Content current as of:
03/20/2019
CLOSEOUT LETTER
Vinill Inc.
MARCS-CMS 564925 —
February 28, 2019
Delivery Method:
United Parcel Service
Recipient:
Recipient Name
Leonid Kats
Recipient Title
Owner
Vinill Inc.
4801 2nd Ave
Brooklyn
,
NY
11232-4220
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Kats:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CMS 564925, September 21, 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 sustinability 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 implemnting 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 andy furture regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/s/
CDR Catherine M. Beer
Director of Compliance
Office of Human and Animal Food Operations
East - Division 1
Content current as of:
03/11/2019
CLOSEOUT LETTER
W & C dba The Apothecary
MARCS-CMS 508183 —
October 22, 2019
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Stephen G. Anderson, R. Ph.
Recipient Title
Owner
W & C dba The Apothecary
165 19th Street South
Suite 102
Sartell
,
MN
56377-2567
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III (PHRM3)
300 River Place
Suite 5900
Detroit
,
MI
48207
United States
(313) 393-8100
Dear Mr. Anderson:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter dated July 20, 2017, (Case #508183). We acknowledge that your firm no longer produces sterile drug products. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to assure 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 Compliance Branch
Division of Pharmaceutical Quality Operations III
Content current as of:
10/30/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Walnut Ridge Farm 1
MARCS-CMS 564117 —
October 24, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Egg/Egg Product
Recipient:
Recipient Name
Samuel T. Peachy
Recipient Title
Owner
Walnut Ridge Farm 1
1657 Pitcher Road
Ovid
,
NY
14521-9799
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 1
158-15 Liberty Avenue
Jamaica
,
NY
11433
United States
Dear Mr. Peachy:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 564117, issued on February 12, 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
11/04/2019
Regulated Product(s)
Food & Beverages
Egg/Egg Product
CLOSEOUT LETTER
The Wellness Center Pharmacy, Inc., dba Designer Drugs
MARCS-CMS 496523 —
February 06, 2019
Product:
Drugs
Recipient:
Recipient Name
Randal J. Davis
Recipient Title
President
The Wellness Center Pharmacy, Inc., dba Designer Drugs
7304 Jarnigan Road
Chattanooga
,
TN
37421
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Mr. Davis:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #2016-NOL-11 dated August 5, 2016. 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 assure 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/
Jose R. Lopez
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations
Division II
Content current as of:
05/23/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Wellness Resources, Inc.
MARCS-CMS 537216 —
May 21, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Mary Guignon/Ryan J. Richards
Recipient Title
Owner and CEO/General Manager
Wellness Resources, Inc.
7155 Amundson Avenue
Edina
,
MN
55439-2020
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
(612) 334-4100
Dear Ms. Guignon and Mr. Richards:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 537216 dated November 30, 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/
Boun M. Xiong
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
05/22/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Xcel Sports Nutrition, LLC
MARCS-CMS 491533 —
November 26, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Donald Clement
Xcel Sports Nutrition, LLC
7408 82nd Street
Lubbock
,
TX
79424
United States
Issuing Office:
Division of Enforcement
United States
Dear Mr. Donald Clement:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #491533, issued March 7, 2016. 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:
05/21/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Yoder Farm Organics
MARCS-CMS 540469 —
February 22, 2019
Delivery Method:
UPS
Recipient:
Recipient Name
Raymond D. Yoder
Recipient Title
Owner
Yoder Farm Organics
21444 Ice Avenue
Bloomfield
,
IA
52537
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
913-495-5100
Dear Mr. Yoder:
The Food and Drug Administration has completed an evaluation of WR Yoder dba WRC Yoder Farm corrective actions in response to our Warning Letter (CMS Case #: 540469) on February 16, 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/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
03/08/2019
CLOSEOUT LETTER
5150 Premium Vape Fluid, Inc.
MARCS-CMS 608111 —
July 21, 2020
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Robin Colbran and Jy Colbran
5150 Premium Vape Fluid, Inc.
11203 SE Pheasant Ridge Dr.
Happy Valley
,
OR
97086
United States
info@5150eliquid.com
5150premiumvapefluid@gmail.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Robin Colbran and Jy Colbran:
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 May 26, 2020, June 5, 2020, June 15, 2020, and July 7, 2020, in response to our Warning Letter dated May 22, 2020. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://5150eliquid.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
cc:
5150 Premium Vape Fluid, Inc.
Attn: Robin Colbran and Jy Colbran
12042 SE Sunnyside Rd, #406
Clackamas, OR 97015
Domains By Proxy, LLC
5150ELIQUID.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
07/28/2020
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
77 Elektronika Kft.
MARCS-CMS 458367 —
May 29, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Sandor Zettwitz
Recipient Title
Managing Director
77 Elektronika Kft.
Budapest
Fehervari ut 98
1116
Hungary
Issuing Office:
"OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality"
United States
Dear Mr. Zettwitz:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #458367 dated October 8, 2015). Based on our evaluation, it appears that your firm has 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 yours,
/S/
Courtney H. Lias, Ph.D.
Deputy Director for Patient Safety and Product
Quality
Office of In Vitro Diagnostics and Radiological
Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
06/12/2020
Regulated Product(s)
Medical Devices