tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Mooncup LTD
MARCS-CMS 495541 —
May 18, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Su Hardy
Recipient Title
Managing Director
Mooncup LTD
Vantage Point
New England Road
Brighton
BN1 4GW
United Kingdom
Issuing Office:
"OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, Office of Product Evaluation and Quality"
United States
Dear Ms. Hardy:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS# 495541, dated May 27, 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 yours,
/S/
Sharon M. Andrews
Director
DHT3B: Division of Reproductive,
Gynecology and Urology Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
US Agent
Kevin Walls
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton, CO 80127
Content current as of:
05/26/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Mylan Pharmaceuticals Inc.
MARCS-CMS 557903 —
May 11, 2020
Product:
Drugs
Recipient:
Recipient Name
Ms. Heather Bresch
Recipient Title
Chief Executive Officer
Mylan Pharmaceuticals Inc.
1000 Mylan Boulevard
Canonsburg
,
PA
15317
United States
Issuing Office:
Office of Pharmaceutical Quality Operations Division I
United States
(973) 331-4900
Dear Ms. Bresch:
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 #557903], dated November 9, 2018, and subsequent Regulatory Meeting held on April 17, 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 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/
Diana Amador-Toro
Program Division Director/District Director
Office of Pharmaceutical Quality Operations
Division I/New Jersey District Office
Content current as of:
05/12/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Napa Valley Bioscience
MARCS-CMS 548342 —
January 22, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
David Murphy
Recipient Title
President
Napa Valley Bioscience
2118 Wilshire Blvd.
Suite 155
Santa Monica
,
CA
90403
United States
Issuing Office:
Office of Compliance
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Murphey:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #548342, issued May 18, 2018. 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:
02/03/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
NeuroScience Solutions, Inc. dba NeuroScience
MARCS-CMS 576310 —
February 11, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. William Sevold
NeuroScience Solutions, Inc. dba NeuroScience
373 280th Street
Osceola
,
WI
54020
United States
Issuing Office:
Division of Enforcement
United States
Dear Mr. Sevold:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 576310, issued April 10, 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 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
Nor-Scot Trading Limited
MARCS-CMS 587076 —
October 22, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
RW1901136
Recipient:
Recipient Name
William Stewart
Nor-Scot Trading Limited
United States
info@nor-scot.com
Issuing Office:
Center for Tobacco Products
United States
Dear William Stewart:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated July 17, 2019. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter for the website http://www.nor-scot.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure 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:
10/26/2020
CLOSEOUT LETTER
North Texas Vapor Shop
MARCS-CMS 589383 —
November 02, 2020
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW1901147
Recipient:
Recipient Name
Jeremy Speight
North Texas Vapor Shop
347 East Hickory Street
Denton
,
TX
76201
United States
BigTexVaporShop@gmail.com
Issuing Office:
Division of Promotion, Advertising, and Labeling
United States
Dear Jeremy Speight:
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, both dated October 3, 2019, in response to our Warning Letter dated September 27, 2019. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter regarding your website https://bigtexvaporshop.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
VIA UPS
cc:
Big Tex Vapor Bar
Attn: Thao M. Huynh
324 E. McKinney Street
Denton, Texas 76201
Content current as of:
11/25/2020
CLOSEOUT LETTER
Nurse Assist, Inc
MARCS-CMS 524298 —
April 01, 2020
Delivery Method:
UPS Overnight
Product:
Medical Devices
Recipient:
Recipient Name
Kevin J. Seifert
Recipient Title
President and Chief Executive Officer
Nurse Assist, Inc
4409 Haltom Road
Haltom City
,
TX
76117
United States
Issuing Office:
Office of Medical Devices and Radiological Health Division III
United States
Dear Mr. Seifert:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated May 8, 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/
Jessica Mu,
Director, Compliance Branch
Office of Medical Devices and
Radiological Health, Division III
Content current as of:
04/10/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Nutrishare Inc
MARCS-CMS 543730 —
March 04, 2020
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Rodney J. Okamoto
Recipient Title
Owner and President
Nutrishare Inc
9850 Kent Street
Elk Grove
,
CA
95624
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
(313) 393-8100
Dear Mr. Okamoto:
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 #543730, January 16, 2018]. 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
cc: Gregory M. Killmeier
Operations Manager & Pharmacist in Charge
Nutrishare Inc.
11020 Plantside Drive
Louisville, KY 40299-6105
Content current as of:
03/04/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Nutritional Engineering Inc
MARCS-CMS 527965 —
March 31, 2020
Delivery Method:
United Parcel Service
Reference #:
527965-17
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Theodore L. Laoudis
Recipient Title
President
Nutritional Engineering Inc
1208 Avenida Chelsea
Vista
,
CA
92083-8315
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Mr. Doe:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 527965-17 dated September 29, 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
04/24/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Ocular Therapeutix Inc.
MARCS-CMS 564663 —
September 02, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Ms. Nicole Oliynyk
Recipient Title
Senior Director, Regulatory Affairs
Ocular Therapeutix Inc.
24 Crosby Drive
Bedford
,
MA
01730
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Ms. Oliynyk:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 564663, dated October 18, 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 yours,
/S/
for Malvina B. Eydelman, M.D.
Director
Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
03/02/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Okamoto Rubber Products Co., Ltd.
MARCS-CMS 604564 —
July 08, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Hideki Kaneuji
Recipient Title
President
Okamoto Rubber Products Co., Ltd.
60/50, 60/51 Moo.19 Navanakorn Industrial Estate Zone 2
Klongnueng
,
Klongluang
Pathum Thani
12120
Thailand
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Hideki Kaneuji:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS# 604564), dated February 14, 2020. 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 yours,
/S/
Sharon M. Andrews
Director
DHT3B: Division of Reproductive,
Gynecology and Urology Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
US AGENT:
Mr. Yu Tadano
Okamoto U.S.A., Inc.
3130 West Monroe Street
Sandusky, Ohio 44870
yutadano@okamotousa.com
Content current as of:
02/02/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
One Way Drug LLC dba Partell Specialty Pharmacy
MARCS-CMS 573455 —
June 16, 2020
Product:
Drugs
Recipient:
Recipient Name
Robert A. Seik
Recipient Title
CEO, Owner
One Way Drug LLC dba Partell Specialty Pharmacy
5835 S. Eastern Ave.
Ste 101
Las Vegas
,
NV
89119-3031
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
(949) 608-2900
Dear Mr. Seik:
The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter, CMS 573455, dated March 13, 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.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
06/23/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Option Care Enterprises
MARCS-CMS 538040 —
July 01, 2020
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
John C. Rademacher
Recipient Title
President and CEO
Option Care Enterprises
3000 Lakeside Drive
Suite 300N
Bannockburn
,
IL
60015-5405
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
(313) 393-8100
Dear Mr. Rademacher:
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 September 28, 2017. 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
Director Compliance Branch
Division of Pharmaceutical Quality Operations III
Content current as of:
07/10/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Option Care Enterprises, Inc.
MARCS-CMS 523000 —
April 23, 2020
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Mr. Douglas L. Dumler
Recipient Title
General Manager
Option Care Enterprises, Inc.
9140 Guilford Road
Suite K
Columbia
,
MD
21046-1811
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
(973) 331-4900
Dear Mr. Dumler:
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 #523000) dated July 20, 2017. 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.
Please send your electronic inquiries to
orapharm1_responses@fda.hhs.gov
. Please identify your response with FEI: 3012335395 and Warning Letter - WL #523000.
If you have any questions, contact Compliance Officer Juan Jimenez at
juan.jimenez@fda.hhs.gov
or
518-453-2314
X-1014.
Diana Amador-Toro
/S/
Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District
Content current as of:
06/17/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
OriGen Biomedical, Inc.
MARCS-CMS 569074 —
July 29, 2020
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Elizabeth San Segundo
Recipient Title
President and CEO
OriGen Biomedical, Inc.
7000 Burleson Rd.
Bldg. D
Austin
,
TX
78744
United States
Issuing Office:
Office of Medical Device and Radiological Health Operations Division 3West
United States
Dear Ms. San Segundo:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated December 20, 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/
Jessica Mu,
Director, Compliance Branch
Office of Medical Devices and
Radiological Health, Division III
Content current as of:
07/30/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Original Living Coconut, LLC
MARCS-CMS 561493 —
June 15, 2020
Delivery Method:
VIA UPS
Product:
Food & Beverages
Ice Cream/Frozen Dairy
Recipient:
Recipient Name
Ms. Renee E. Ainlay
Original Living Coconut, LLC
817 W. Arnold Wallen Way
Stockton
,
MO
65785
United States
Issuing Office:
Office of Human and Animal Food-West Div. 2
United States
913-495-5100
Dear Ms. Ainlay:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 561493) on October 10, 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/
Andrew A. Hoopes
Compliance Officer
Office of Human and Animal Food-West Div. 2
Content current as of:
06/29/2020
Regulated Product(s)
Food & Beverages
Ice Cream/Frozen Dairy