tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Milos Inc. dba Estiatorio Milos
MARCS-CMS 538563 —
November 09, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Costas Spilliadis, Mr. George Spilliadis, Ms. Evridiki Spilliadis
Recipient Title
CEO and Co-owners
Milos Inc. dba Estiatorio Milos
125 W. 55th Street
New York
,
NY
10019
United States
Issuing Office:
New York District Office
United States
Dear Messrs. Spilliadis:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 538563 dated October 4, 2017. Based on our evaluation, it appears that you have addressed the violation 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/
Anna Alexander
Compliance Director
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration
Content current as of:
11/29/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
The Mineral Store, Inc./Elemental Research, Inc.
MARCS-CMS 609178 —
January 28, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Anette Hasalone and Mr. Jason Brunson
The Mineral Store, Inc./Elemental Research, Inc.
4353 East Poleline Avenue
Post Falls
,
ID
83854
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Mr. Jason Brunson
The Mineral Store, Inc.
315 North 400 West, Suite B
Fillmore, UT 84631
Dear Mr. Brunson and Ms. Hasalone:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 609178, issued October 9, 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/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
02/02/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
MJM Distribution Inc dba Asheville Vapor
MARCS-CMS 614935 —
July 28, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2101608
Product:
Tobacco
Recipient:
Recipient Name
Michael Cotellese
MJM Distribution Inc dba Asheville Vapor
2144 Hendersonville Rd.
Ste. B
Arden
,
NC
28704
United States
sales@mjmdistro.com
Issuing Office:
Center for Tobacco Products
United States
Dear Michael Cotellese:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your Warning Letter responses dated June 16, 2021 and July 9, 2021, in response to our Warning Letter dated May 28, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.mjmdistribution.net.
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/
Mallory Bowling
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
Shopify, Inc.
abuse@shopify.com
GoDaddy.com, LLC
abuse@godaddy.com
Content current as of:
07/30/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Mytilini Enterprises LLC dba Bedford Pharmacy Inc.
MARCS-CMS 486159 —
January 11, 2021
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Charles J. Fanaras
Recipient Title
President
Mytilini Enterprises LLC dba Bedford Pharmacy Inc.
209 Route 101
Bedford
,
NH
03110-5440
United States
Issuing Office:
OPQO Division I / New Jersey District
United States
(973) 331-4900
Dear Mr. Fanaras:
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 # 486159), dated May 18, 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.
Send your communications to
orapharm1_responses@fda.hhs.gov
Please identify your correspondence with FEI: 3003687986.
If you have any questions, contact Compliance Officer Juan Jimenez at
518-453-2314
X-1014 or
juan.jimenez@fda.hhs.gov
.
Craig W. Swanson
For Diana Amador-Toro
Program Division director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District
Content current as of:
01/15/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Nature’s Boost LLC
MARCS-CMS 609846 —
April 13, 2021
Delivery Method:
Overnight Delivery
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Nathan Howerton
Recipient Title
Member
Nature’s Boost LLC
9805 Northeast 116th Street
Suite A312
Kirkland
,
WA
98034
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
Dear Mr. Howerton:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS 609846, dated November 20, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
cc:
Michael Brandwein
Gordon Law Group, Ltd.
400 Central Avenue, Suite 340
Northfield, Illinois 60093
Nathan Howerton, Member
Nature’s Boost LLC
17146 Beaton Road SE, Suite 5
Monroe, Washington 98272
Content current as of:
04/22/2021
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com
MARCS-CMS 613952 —
September 27, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Edward Mauro
Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com
Nature’s Distributing; Club Clean Inc
107 Pinckney St
Oldsmar
,
FL
34677
United States
Kody@ClubClean.net
Ed@ClubClean.net
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Mauro:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613952, May 28, 2021). 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/
Donna Engleman, MS, BSN
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
10/04/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Nephron Sterile Compounding Center LLC
MARCS-CMS 610867 —
February 19, 2021
Reference #:
ANDA 78202
Product:
Drugs
Recipient:
Recipient Name
Lou Kennedy
Recipient Title
CEO and Owner
Nephron Sterile Compounding Center LLC
4500 12th Street Extension
West Columbia
,
SC
29172
United States
Issuing Office:
Office of Prescription Drug Promotion
United States
Dear Mr. Kennedy:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated September 22, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA surveillance 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 subsequent surveillance or through other means.
If you have any questions or comments, please direct your response to the undersigned at the
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266.
A courtesy copy can be sent by facsimile to
(301) 847-8444
. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP.
Please refer to MA 1, 3 in addition to the ANDA number in all future correspondence relating to this particular matter.
Sincerely,
{See appended electronic signature page}
Taylor Burnett, Pharm.D., RAC
Regulatory Review Officer
Division of Advertising & Promotion Review 2
Office of Prescription Drug Promotion
--------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
--------------------------------------------------------------------------------------------
/s/
------------------------------------------------------------
TAYLOR B BURNETT
02/19/2021 03:55:52 PM
Content current as of:
03/16/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Neptunus Seafood B.V.
MARCS-CMS 599076 —
June 07, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Martin Haasnoot
Recipient Title
Director
Neptunus Seafood B.V.
Rijnlandkade 1
2222 AE
Katwijk
Netherlands
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Haasnoot:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #599076, issued January 22, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Maria Corpuz
Team Leader
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
06/09/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
NeuroHydrate LLC
MARCS-CMS 613092 —
June 21, 2021
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Dietary Supplements
Recipient:
Recipient Name
Hamid Sami, Justin Higgins
Recipient Title
Founding Partner, Managing Partner
NeuroHydrate LLC
United States
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
Dear Mr. Sami and Mr. Higgins:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 613092, issued on April 27, 2021. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
06/23/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
New 88 Japanese Food Trading Inc
MARCS-CMS 592644 —
February 26, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Shao Song (Kevin) Chen and Mr. David Chen
Recipient Title
President and Co-Owner/Vice-President and Co-Owner
New 88 Japanese Food Trading Inc
3305 Farrington Street
Flushing
,
NY
11354-2820
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Dear Messrs. Chen:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 592644 dated November 22, 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 subsequent inspection or through other means.
Sincerely,
/S/
CDR Catherine M. Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East - Division 1
Content current as of:
03/02/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
New Spirit Naturals Inc.
MARCS-CMS 595025 —
December 17, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Dr. Larry J. Milam, PhD
Recipient Title
CEO/President
New Spirit Naturals Inc.
615 W Allen Ave
San Dimas
,
CA
91773
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
Dear Dr. Milam:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 595025 May 7, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
12/28/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Nicoticket LLC
MARCS-CMS 613994 —
June 04, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101557
Product:
Tobacco
Recipient:
Recipient Name
Kent Brooks
Nicoticket LLC
United States
contact@nicoticket.com
privacy@nicoticket.com
Issuing Office:
Center for Tobacco Products
United States
Dear Kent Brooks:
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 March 26, 2021 and April 23, 2021, in response to our Warning Letter dated March 26, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website http://www.nicoticket.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 Electronic Mail
cc:
Enom, Inc.
abuse@enom.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
06/08/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Nicotine Nirvana
MARCS-CMS 614671 —
June 02, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2101591
Product:
Tobacco
Recipient:
Recipient Name
Cliff Loeb
Nicotine Nirvana
United States
Issuing Office:
Center for Tobacco Products
United States
Dear Cliff Loeb:
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 10, 2021, May 21, 2021, May 23, 2021, and May 24, 2021, in response to our Warning Letter dated May 7, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.nicotinenirvana.com.
However, our surveillance shows you continue to offer for sale to customers in the United States other tobacco products that may be subject to market authorization requirements. FDA encourages you to discuss with your suppliers the current status of any particular tobacco product’s marketing application or any product’s marketing authorization. For additional information regarding currently marketed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement, please visit our website
https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-lists?utm_medium=email&utm_source=govdelivery#list%20of%20deemed
.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure 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 Electronic Mail
cc:
Contact Privacy Inc. Customer 0144274739
nicotinenirvana.com@contactprivacy.com
Tucows, Inc.
domainabuse@tucows.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
06/07/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Nuturna International LLC
MARCS-CMS 614577 —
December 16, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Joseph Esposito
Nuturna International LLC
390 North Orange Ave.
Suite 2300
Orlando
,
FL
32801
United States
corporate@nuturna.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Joseph Esposito:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 614577, issued September 7, 2021. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/02/2022
Regulated Product(s)
Dietary Supplements