tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Sovereign Pharmaceuticals, LLC
MARCS-CMS 303858 —
June 04, 2019
Reference #:
2013-DAL-WL-28
Product:
Drugs
Recipient:
Recipient Name
Paul D. Hafey
Recipient Title
President and CEO
Sovereign Pharmaceuticals, LLC
7590 Sand Street
Fort Worth
,
TX
76118
United States
Issuing Office:
Center for Drug Evaluation and Research
4040 N. Central Expressway
Suite 300
Dallas
,
TX
75204
United States
Mr. Hafey:
The Food and Drug Administration has completed evaluation of corrective actions in response to our Warning Letter 2013-DAL-WL-28, dated January 29, 2013. 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/
John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division 2
Content current as of:
06/10/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Spectranetics Corporation
MARCS-CMS 491979 —
May 16, 2019
Product:
Medical Devices
Recipient:
Recipient Name
Christopher Barys
Recipient Title
Business Leader
Spectranetics Corporation
Philips Image Guided Therapy Devices
3721 Valley Centre Sr.
Ste. 500
San Diego
,
CA
92130
United States
Issuing Office:
Center for Devices and Radiological Health
19701 Fairchild
Irvine
,
CA
92612
United States
Dear Mr. Barys:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [DEN-16-08-WL dated May 23, 2016]. 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/
Jeffrey R. Wooley
Director of Compliance Branch
Office of Medical Device and Radiological Health
Division 3/West
cc:
Ms. Lindsay Pack
Spectranetics Corporation
9965 Federal Dr.
Colorado Springs, CO 80921
Content current as of:
05/21/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
S.S.O., Inc dba BYS Company
MARCS-CMS 496434 —
October 09, 2019
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
James W. Sims
Recipient Title
President
S.S.O., Inc dba BYS Company
18273 Grand Ave.
#5&8
Lake Elsinore
,
CA
92530-6118
United States
Issuing Office:
Center for Food Safety and Nutrition
19701 Fairchild
Irvine
,
CA
92612
United States
Dear Mr. Sims:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 49-16 issued September 23, 2016 (CMS # 496434). 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/
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild
Irvine, CA 92612
Content current as of:
10/21/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Stanmore Implants Worldwide Ltd.
MARCS-CMS 444402 —
May 03, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Michael Mainelli
Recipient Title
Chief Executive Officer
Stanmore Implants Worldwide Ltd.
210 Centennial Avenue
Elstree
WD6 3SJ
United Kingdom
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Mainelli:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (Case #444402), issued on November 26, 2014. 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/
CAPT Raquel Peat, PhD, MPH, USPHS
Director
Office of Health Technology 6
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
cc: Establishment File
Home District of Corporate HQ (or of receiving firm if issued by a Center)
FOI Office for Posting
CMS case file (electronic copy)
Content current as of:
05/31/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Stonegate Pharmacy LP
MARCS-CMS 505526 —
April 24, 2019
Delivery Method:
UPS EXPRESS
Product:
Drugs
Recipient:
Recipient Name
Rene F. Garza, PharmD
Recipient Title
Chief Executive Officer
Stonegate Pharmacy LP
2501 W. William Cannon Drive
Suite 203
Austin
,
TX
78745
United States
Issuing Office:
Center for Drug Evaluation and Research
4040 N. Central Expressway
Suite 300
Dallas
,
TX
75204
United States
Dr. Garza:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [2017-DAL-WL-03, dated November 10, 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/
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
05/07/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Sweet Ann Cake, Inc.
MARCS-CMS 590155 —
October 29, 2019
Delivery Method:
VIA Electronic Mail
Reference #:
23-HAFE4-WLCOL-02
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Francisco Aguayo
Recipient Title
President/Owner
Sweet Ann Cake, Inc.
Carretera 867, Km 7.8, Lote #3
Calle Bruno Cruz, Zona Industrial
Toa Baja
00949
Puerto Rico
f.aguayo@asmetalpr.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV
United States
Dear Mr. Aguayo:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions as evidenced in our inspection conducted from February 8-21, 2023 (dates not all inclusive). This inspection served as a follow up to our Warning Letter, 20-HAFE4-WL-02 dated October 29, 2019. Based on our evaluation It appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The 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/
Pearl Lopina
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
03/14/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
SynCardia Systems LLC
MARCS-CMS 537226 —
June 11, 2019
Delivery Method:
United Parcel Service
Product:
Medical Devices
Recipient:
Recipient Name
Don Webber
Recipient Title
Chief Operating Officer
SynCardia Systems LLC
1992 East Silverlake Road
Tucson
,
AZ
85713
United States
Issuing Office:
Center for Devices and Radiological Health
19701 Fairchild Road
Los Angeles
,
CA
92612
United States
Dear Mr. Webber,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #537226), dated 04/03/2018. 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/
Bryan Love
Acting Compliance Branch Director
Division 3/West
Office of Medical Device and Radiological Health Operations
Content current as of:
07/18/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Tecres S.p.A.
MARCS-CMS 459252 —
August 20, 2019
Delivery Method:
UPS
Product:
Medical Devices
Recipient:
Recipient Name
Giovanni Faccioli
Recipient Title
President
Tecres S.p.A.
Via Andrea Doria 6
Sommacapagna
37066
Veneto
VR
Italy
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Giovanni Faccioli:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 459252, dated August 14, 2015). Based on our evaluation, it appears that your firm has 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/
CAPT Raquel Peat, PhD, MPH, USPHS
Director
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC: US Agent
Cristine Brauer
Brauer Device Consultants, LLC.
7 Trail House Court
0Rockville, MD 20850
Content current as of:
08/28/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
TEK Naturals
MARCS-CMS 565026 —
June 04, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Trevor Rose
TEK Naturals
1985 Riviera Dr.
103-127
Mount Pleasant
,
SC
29464
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Rose:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 565026, issued February 5, 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/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
CC: Richard D. Collins, Esq.
Collins Gann McCloskey & Barry, PLLC
138 Mineola Blvd.
Mineola, NY 11501
Content current as of:
06/10/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
TELEMED
MARCS-CMS 540646 —
May 24, 2019
Product:
Medical Devices
Recipient:
Recipient Name
Dmitry Novikov
Recipient Title
President
TELEMED
Dariaus ir Gireno 42
02189
Vilnius
Lithuania
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Novikov:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 540646. 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/
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Product Engineering and Quality
Center for Devices and Radiological Health
Content current as of:
05/31/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Thai Fishsauce Factory Co., Ltd.
MARCS-CMS 540119 —
May 17, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Poraya Kunatien
Recipient Title
Managing Director
Thai Fishsauce Factory Co., Ltd.
21/5 – 21/7 Trok Rongnamkeng
Charoenkrung 24 Road
Taladnoi
,
Samphantawong
Bangkok
10100
Thailand
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Ms. Kunatien:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #540119, issued December 12, 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/
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
06/10/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Thor Inc.
MARCS-CMS 517472 —
March 08, 2019
Delivery Method:
UPS Overnight
Recipient:
Recipient Name
Eric Glanville
Recipient Title
President
Thor Inc.
1280 West 2550 South
Ogden
,
UT
84401-3238
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Glanville:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-17-05-WL, dated May 1, 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/
LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Food Operations -
Division IV West
Content current as of:
03/18/2019
CLOSEOUT LETTER
Thornton Enterprises DBA The Donut Stop
MARCS-CMS 544523 —
June 26, 2019
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Cole and Heather Thornton
Recipient Title
Owners
Thornton Enterprises DBA The Donut Stop
606 W. Sheridan Ave.
Shenandoah
,
IA
51601
United States
Issuing Office:
Division of Human and Animal Food Operations West II
8050 Marshall Drive, Suite 205
Lenexa
,
KS
66214-1524
United States
June 26, 2019
DELIVERY VIA UPS
WARNING LETTER CLOSE-OUT LETTER
Cole and Heather Thornton, Owners
Thornton Enterprises dba The Donut Stop
606 W. Sheridan Ave.
Shenandoah, IA 51601
Dear Mr. & Mrs. Thornton:
The Food and Drug Administration has completed an evaluation of Thornton Enterprises dba The Donut Shop corrective actions in response to our Warning Letter (CMS case #: 544523) on March 19, 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:
06/27/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Total Body Nutrition
MARCS-CMS 578270 —
June 17, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Mohammad Islam
Recipient Title
President
Total Body Nutrition
100 Executive Dr.
Suite A
Edgewood
,
NY
11717
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Islam:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS #578270, dated April 11, 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/
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:
03/20/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
TriMed, Inc.
MARCS-CMS 494255 —
October 11, 2019
Delivery Method:
UPS Overnight
Product:
Medical Devices
Recipient:
Recipient Name
David H. Medoff
Recipient Title
CEO
TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita
,
CA
91355
United States
Issuing Office:
Center for Devices and Radiological Health
19701 Fairchild
Irvine
,
CA
92612
United States
Dear Mr. Medoff:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated June 30, 2016. 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/
Jamie M. Bumpas
Acting Director, Compliance Branch
Content current as of:
10/21/2019
Regulated Product(s)
Medical Devices