tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
NYX E Cigarettes Incorporated
MARCS-CMS 605739 —
June 25, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2001278
Product:
Tobacco
Recipient:
Recipient Name
Michael Blanca
NYX E Cigarettes Incorporated
United States
support@nyxecigs.com
sales@nyxecigs.com
Issuing Office:
Center for Tobacco Products
United States
Dear Michael Blanca:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your response dated July 13, 2020, in response to our Warning Letter dated March 27, 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://www.nyxecigs.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:
Domains By Proxy, LLC
NYXECIGS.COM@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Shopify, Inc.
abuse@shopify.com
Content current as of:
06/28/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Only Natural, Inc. dba Bio Nutrition, Inc.
MARCS-CMS 605076 —
July 29, 2021
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Steven Myers
Recipient Title
President
Only Natural, Inc. dba Bio Nutrition, Inc.
3055 New Street
Oceanside
,
NY
11572
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Dear Mr. Myers:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 605076, issued on June 18, 2021. Since issuance of the Warning Letter, there have been changes in the responsible firm operations. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter pertaining to your firm. 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:
07/30/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Paisley Farms, LLC dba Paisley Farm & Crafts
MARCS-CMS 575934 —
March 31, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Linda F. Ogburn
Recipient Title
Owner
Paisley Farms, LLC dba Paisley Farm & Crafts
252 S. Hood Road
Lawrenceburg
,
TN
38464-6541
United States
Issuing Office:
Division of Human and Animal Food Operations East V
United States
Dear Ms. Ogburn:
The Food and Drug Administration (FDA) completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 575934. Based on our evaluation, it appears 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/
Zada L. Giles
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East
Content current as of:
04/08/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Perfection Vapes Inc
MARCS-CMS 612783 —
June 04, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW2101464
Product:
Tobacco
Recipient:
Recipient Name
Victor Canastraro
Perfection Vapes Inc
5860 Transit Rd.
Depew
,
NY
14043
United States
victor@perfectionvapes.com
Issuing Office:
Center for Tobacco Products
United States
Dear Victor Canastraro:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your response dated February 1, 2021, in response to our Warning Letter dated January 15, 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.perfectionvapes.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:
Launchpad.com (HostGator)
abuse@websitewelcome.com
Content current as of:
06/09/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Pero Family Farms Food Company LLC
MARCS-CMS 608227 —
April 22, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
20-HAFE4-WL-06
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Peter Pero
Recipient Title
Chief Executive Officer
Pero Family Farms Food Company LLC
14095 US Highway 441
Delray Beach
,
FL
33446-9600
United States
peter.pero@perofamilyfarms.com
angela.pero@perofamilyfarms.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
Dear Mr. Pero:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 20-HAFE4-WL-06, dated August 10, 2020. 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:
04/26/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
The Philosopher's Stone, LLC
MARCS-CMS 613737 —
July 09, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101532
Product:
Tobacco
Recipient:
Recipient Name
Kristopher Eickhoff
The Philosopher's Stone, LLC
United States
ike@tpsvapor.com
Issuing Office:
Center for Tobacco Products
United States
Dear Kristopher Eickhoff:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your e-mails received by FDA on March 25, 2021 and April 12, 2021, in response to our Warning Letter dated March 12, 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.tpsvapor.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/
Mallory Johnson
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
1&1 Internet Inc.
dataprivacyprotected@1und1.de
1&1 IONOS SE
abuse@ionos.com
Weebly, Inc.
weebly-abuse@squareup.com
Content current as of:
07/20/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Predator Nutrition
MARCS-CMS 607136 —
January 28, 2021
Recipient:
Recipient Name
Mr. Daniel RG Hoare
Predator Nutrition
62 Broomfield Avenue
Halifax, West Yorkshire
HX30JF
United Kingdom
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Hoare:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 607136, issued October 23, 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
Content current as of:
01/29/2021
CLOSEOUT LETTER
Professional World Store
MARCS-CMS 612406 —
September 27, 2021
Product:
Medical Devices
Recipient:
Professional World Store
167-43 147th Ave.
Jamaica
,
NY
11434
United States
info@professionalworldstore.com
Issuing Office:
Center for Devices and Radiological Health
United States
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 612406, April 27, 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
ProHealth Inc.
MARCS-CMS 612227 —
June 25, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Richard D. Carson
Recipient Title
CEO
ProHealth Inc.
555 Maple St.
Carpinteria
,
CA
93013
United States
bbrunsman@prohealth.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Carson,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 612227, issued February 18, 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:
07/21/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Proper Nutrition Inc.
MARCS-CMS 612435 —
October 05, 2021
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Dr. Leonard C. Giunta
Recipient Title
President
Proper Nutrition Inc.
439 S. Bolmar Street
West Chester
,
PA
19382-4933
United States
Issuing Office:
Human and Animal Food Division II East
United States
Dear Dr. Leonard C. Giunta,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter with CMS#612435, dated April 20, 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/
Daniel W. Johnson
Compliance Officer
HAF Division East 2, Philadelphia Office
Office p hone: 215.717.3746
e-mail: Daniel.Johnson@fda.hhs.gov
Content current as of:
11/10/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Quality Dairy Company
MARCS-CMS 614395 —
April 23, 2021
Delivery Method:
VIA UPS
Reference #:
FY20-HAFE6-03
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Ken Martin
Recipient Title
President
Quality Dairy Company
1335 Diamond Reo Way
Lansing
,
MI
48910-1464
United States
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Dear Mr. Martin:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY20-HAFE6-03 dated May 13, 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,
/S/
Audrey De La Cruz
Acting Compliance Branch Director,
FDA/ORA/OHAFO East-6
Content current as of:
05/12/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Queten Research Institute
MARCS-CMS 610021 —
June 28, 2021
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Jill Seropian
Recipient Title
VP
Queten Research Institute
10 Bloomfield Ave.
Pine Brook
,
NJ
07058
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Dear Ms. Seropian:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued to Queten Research Institute on November 5, 2020. Based on our evaluation, it appears that your firm has adequately 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/
Andrew Ciaccia
Compliance Officer
Human and Animal Food East, Division II
Content current as of:
07/02/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Red Moon Herbs
MARCS-CMS 607640 —
January 28, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Jeanette Dunn Acevedo
Red Moon Herbs
433 Weaverville Hwy
Suite A
Asheville
,
NC
28804
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Ms. Dunn Acevedo:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 607640, issued November 18, 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:
02/01/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Reproductive Technologies, Inc.
MARCS-CMS 594292 —
December 03, 2021
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
#OBPO 20-594292
Product:
Biologics
Recipient:
Recipient Name
Ms. Alice H. Ruby
Recipient Title
Executive Director
Reproductive Technologies, Inc.
2115 Milvia Street
Suite 201
Berkeley
,
CA
94704
United States
Issuing Office:
Office of Biological Products Operations - Division 2
United States
Dear Ms. Ruby:
The Food and Drug Administration has completed evaluation of Reproductive Technologies, Inc.’s corrective actions in response to our Warning Letter #OBPO 20-594292 dated November 6, 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/
Young Mi Yoon
Compliance Officer
Division 2 Compliance Branch
Office of Biological Products Operations (OBPO)
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
12/14/2021
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Results RNA, LLC
MARCS-CMS 578997 —
June 24, 2021
Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs
Recipient:
Recipient Name
David Larson
Recipient Title
CEO and President
Results RNA, LLC
1272 S. 1380 W
Orem
,
UT
84058-4911
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
949-608-2900
Dear Mr. Larson:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #578997 and dated July 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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
07/06/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Revolution Vapor LLC
MARCS-CMS 613743 —
June 04, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101534
Product:
Tobacco
Recipient:
Recipient Name
Eric Swick
Revolution Vapor LLC
United States
Issuing Office:
Center for Tobacco Products
United States
Dear Eric Swick:
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 29, 2021, March 31, 2021 and April 8, 2021, in response to our Warning Letter dated March 12, 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.revolutionvapor.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:
Proxy Protection LLC
Revolutionvapor.com@proxy.dreamhost.com
Cloudflare, Inc.
abuse@cloudflare.com
DreamHost
abuse@dreamhost.com
Content current as of:
06/23/2021
Regulated Product(s)
Tobacco