tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Smoked Salmon Unlimited d.b.a. H. Forman & Son
MARCS-CMS 607398 —
September 29, 2020
Recipient:
Recipient Name
Mr. Lance P. Anisfeld
Recipient Title
CEO/Owner
Smoked Salmon Unlimited d.b.a. H. Forman & Son
Fish Island, Stour Road
London
E3 2NT
United Kingdom
Issuing Office:
Office of Compliance
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Anisfeld:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 607398, issued May 12, 2020. 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 CSO
Center for Food Safety and Applied Nutrition
Division of Enforcement
Office of Compliance
Content current as of:
09/30/2020
CLOSEOUT LETTER
Strong Fertility Center
MARCS-CMS 593262 —
December 11, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
OBPO 20-593262
Product:
Biologics
Recipient:
Recipient Name
Kathleen Hoeger, MD
Recipient Title
Director of Tissue Bank Operations
Strong Fertility Center
500 Red Creek Drive
Suite 220
Rochester
,
NY
14623-4285
United States
Issuing Office:
Office of Biological Products Operations – Division I
United States
Dear Dr. Hoeger:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #OBPO 20-593262 dated October 29, 2019. 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/
Elizabeth Waltrip
Program Division Director
Content current as of:
12/22/2020
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Surgisil, LLP
MARCS-CMS 567886 —
January 23, 2020
Delivery Method:
UPS Overnight
Product:
Medical Devices
Recipient:
Recipient Name
Peter Raphael, MD
Recipient Title
Chief Executive Officer
Surgisil, LLP
6020 W. Plano Parkway
Plano
,
TX
75093
United States
Issuing Office:
Office of Medical Devices and Radiological Health, Division III
United States
Dear Dr. Raphael:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated April 15, 2019. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Jessica Mu,
Director, Compliance Branch
Office of Medical Devices and
Radiological Health, Division III
Content current as of:
09/01/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Surmasis Pharmaceutical
MARCS-CMS 553686 —
June 22, 2020
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Mr. Lorne C. Scharnberg
Recipient Title
CEO
Surmasis Pharmaceutical
4020 Gannett Avenue
Des Moines
,
IA
50321
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
(313) 393-8100
Dear Mr. Scharnberg:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter #553686 dated November 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/
Nicholas F. Lyons
Director of Compliance
Division of Pharmaceutical Quality Operations III
Content current as of:
06/29/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
T & S Dairy
MARCS-CMS 604555 —
May 13, 2020
Delivery Method:
UPS Overnight
Product:
Drugs
Recipient:
Recipient Name
Erna De Boer
Recipient Title
Owner
T & S Dairy
19008 FM 3079
Chandler
,
TX
75758-7667
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 3
United States
Dear Mrs. De Boer,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated April 14, 2020, issued following inspection of your facility located at Private Road 116, Box 7573, Winnsboro, TX 75494. 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 E. Havranek
Director of Compliance
Office of Human and Animal Food, WD3
Content current as of:
05/21/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Talon
MARCS-CMS 580417 —
September 09, 2020
Recipient:
Recipient Name
Norman A. Shoenfeld, MD
Recipient Title
President and Owner
Talon
10625 Telge Road
Houston
,
TX
77095-5023
United States
nshoenfeld@taloncontrols.com
Issuing Office:
Office of Medical Device and Radiological Health Operations, Division 3
United States
Dear Dr. Shoenfeld:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #580417) dated August 2, 2019. 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 Bumpas
Acting Director, Compliance Branch
Office of Medical Device and Radiological Health Operations
Division 3 West
Cc: Clifton Wall, Quality Assurance Manager (MR)
cwall@taloncontrols.com
Content current as of:
09/15/2020
CLOSEOUT LETTER
Techni Med, Inc. dba The Compounder
MARCS-CMS 493750 —
May 05, 2020
Delivery Method:
UPS Next Day
Reference #:
CHI-10-16
Product:
Drugs
Recipient:
Recipient Name
Lawrence J. Frieders
Recipient Title
Owner and Pharmacist in Charge
Techni Med, Inc. dba The Compounder
340 Marshall Avenue
Unit 100
Aurora
,
IL
60506-5649
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
(313) 393-8100
Dear Mr. Frieders:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL #CHI-10-16) dated July 29, 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 ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III
Content current as of:
05/12/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Terumo Medical Corporation
MARCS-CMS 483231 —
January 08, 2020
Delivery Method:
United Parcel Service
Product:
Medical Devices
Recipient:
Recipient Name
James Rushworth
Recipient Title
President/CEO
Terumo Medical Corporation
2101 Cottontail Lane
Somerset
,
NJ
08873
United States
Issuing Office:
Division of Medical Device and Radiological Health Operations East
United States
Dear Mr. Rushworth:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, CMS# 483231, dated March 17, 2016 for your firm’s Elkton, MD location. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means
Sincerely,
/S/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Devices & Radiological Health
Division One - East
Content current as of:
01/15/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Tosoh Bioscience Inc
MARCS-CMS 505636 —
March 25, 2020
Delivery Method:
Via Email
Recipient:
Recipient Name
Yoshiyuki Shindo
Recipient Title
President
Tosoh Bioscience Inc
6000 Shoreline Ct. #101
South San Francisco
,
CA
94080
United States
yoshiyuki.shindo@tosoh.com
Issuing Office:
Office of Medical Devices and Radiological Health Operations (Division 1)
United States
Dear Mr. Shindo:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CIN 16-505636-19, dated August 5, 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.
You may direct any questions or comments regarding this letter to Amy Cramer at
amy.cramer@fda.hhs.gov
or at
732-390-3822
.
Sincerely,
/S/
Gina M. Brackett
Director Compliance Branch
Office of Medical Device & Radiological Health Operations
Division 1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration
cc: Dave Wurtz, Director Quality & Compliance,
dave.wurtz@tosoh.com
Content current as of:
03/25/2020
CLOSEOUT LETTER
Tubilux Pharma Spa
MARCS-CMS 523119 —
March 09, 2020
Reference #:
320-17-41
Recipient:
Recipient Name
Emidio Fedeli
Recipient Title
President and CEO
Tubilux Pharma Spa
Via Costarica 20/22
00071
Rome
Italy
Issuing Office:
Division of Drug Quality II
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Fedeli:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-41 dated July 6, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
LCDR Matthew Schnupp, PharD.
Compliance Officer
Division of Drug Quality II
Office of Manufacturing Quality
CDER/Office of Compliance
Content current as of:
03/18/2020
CLOSEOUT LETTER
TYRX Inc.
MARCS-CMS 497549 —
April 17, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
16-NWJ-08
Product:
Medical Devices
Recipient:
Recipient Name
Omar S. Ishrak
Recipient Title
Chief Executive Officer
TYRX Inc.
710 Medtronic Parkway
Minneapolis
,
MN
55432
United States
omar.ishrak@medtronic.com
Issuing Office:
Office of Medical Device and Radiological Health Operations Division 2
United States
(407) 475-4700
Dear: Mr. Ishrak:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 16-NWJ-08 CMS # 497549. 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/
Demetria L. Lueneburg
Compliance Officer
Office of Medical Device and Radiological Health Operations (OMDRHO)
Division 2 – Central
Content current as of:
04/27/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
U.S. Dairy Unlimited, LLC
MARCS-CMS 590413 —
March 09, 2020
Delivery Method:
UPS Next Day
Reference #:
20-HAFE4-WL-03
Recipient:
Recipient Name
Mr. Uri Zyman
Recipient Title
Owner
U.S. Dairy Unlimited, LLC
3301 NW 168th Street
Miami
,
FL
33056
United States
Issuing Office:
Office of Human and Animal Foods Division 4 East
United States
(787) 729-8500
Dear Mr. Zyman:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 20-HAFE4-WL-03 dated November 19, 2019. It appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO, Division IV East
Content current as of:
03/12/2020
CLOSEOUT LETTER
US Vascular LLC
MARCS-CMS 554761 —
March 18, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Galen T. Spooner
Recipient Title
Owner
US Vascular LLC
PO Box 199
Beaverton
,
OR
97075
United States
mailto:gus@vasculab.com
Issuing Office:
Office of Medical Device and Radiological Health Division 3/West
United States
Dear Mr. Spooner:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [WL CMS 554761 dated June 7, 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/
Jessica Mu
Director of Compliance Branch
Office of Medical Device and Radiological Health
Division 3/West
Content current as of:
03/20/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Van Tibolli, LLC., dba GK Hair
MARCS-CMS 451478 —
May 26, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
20-HAFE4-WLCOL-08
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Van Tibolli
Recipient Title
CEO
Van Tibolli, LLC., dba GK Hair
1607 Ave. Ponce de Leon
San Juan
,
PR
00909-1820
United States
van.tibolli@VTBeauty.com
Issuing Office:
Office of Human and Animal Food Operations Division IV East
United States
(787) 729-8500
Dear Mr. Tibolli:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, FLA 15-31 dated September 2, 2015. 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 your responsibility of assuring that your establishment is in compliance with the Federal Food, Drug, and Cosmetic Act and its 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 any questions, contact Pearl Lopina, Compliance Officer at
407-475-4730
or
pearl.lopina@fda.hhs.gov
.
Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO Division IV East
Content current as of:
05/26/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Vape Game LLC
MARCS-CMS 607462 —
August 10, 2020
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001297
Recipient:
Recipient Name
Dalton Baarstad, Terri Baarstad, Taylor Jones, and Ben Sandreth
Vape Game LLC
120 Cleveland St.
Ste 4
Eugene
,
OR
97402
United States
taylor@vape-game.com
dalton@vape-game.com
wholesale@vape-game.com
vapegamelabs@gmail.com
ben@vape-game.com
Issuing Office:
Center for Tobacco Products
United States
Dear Dalton Baarstad, Terri Baarstad, Taylor Jones, and Ben Sandreth:
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 April 30, 2020 and July 31, 2020, in response to our Warning Letter dated April 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://vapegame.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
Content current as of:
11/05/2020
CLOSEOUT LETTER
VapeCentric, Inc.
MARCS-CMS 607375 —
November 20, 2020
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2001268
Recipient:
Recipient Name
Michael Daneshrad
VapeCentric, Inc.
30101 Agoura Court
Suite 233
Agoura Hills
,
CA
91301
United States
sales@vapecentric.com
mike@vapecentric.com
Issuing Office:
Office of Compliance and Enforcement
United States
Dear Michael Daneshrad:
On April 27, 2020, the Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) issued a Warning Letter informing you that your e-liquid product (e.g. Pink Sticks) was adulterated under section 902(6)(A) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting this product was not provided as required by section 905(j) of the FD&C Act. In addition, a conference call was held between FDA and VapeCentric, Inc. (VapeCentric) on August 17, 2020.
On May 18, 2020 and September 27, 2020, FDA received response letters from Phil Daman, Esq. at Daman & Associates, LLP on behalf of VapeCentric, representing that corrective actions were taken to address the violation identified in the Warning Letter and related concerns.
Based upon our evaluation, it appears the stated corrections have been made.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure compliance with the FD&C Act and its implementing regulations or other relevant legal authority. This letter will not preclude regulatory action should violations be observed in the future.
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at
(301) 796-9235
or via email at
CTPCompliance@fda.hhs.gov
.
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
Michael Daneshrad
5015 Blackpool Avenue
Oak Park, CA 91377
Phil Daman, Esq.
369 Lexington Ave., 3rd Floor
New York, NY 10017
phillip.daman@damanllp.com
GoDaddy.com, LLC
abuse@godaddy.com
Google, LLC
google-cloud-compliance@google.com
Content current as of:
12/01/2020