tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Smooth Vapes, Inc.
MARCS-CMS 613514 —
June 04, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101515
Product:
Tobacco
Recipient:
Recipient Name
Angela Goodman
Smooth Vapes, Inc.
United States
smoothvapes@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Angela Goodman:
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 15, 2021 and April 13, 2021, in response to our Warning Letter dated February 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://smooth-vapes.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:
Attn: Mike Khalil
Mike.k@jjccgroup.org
GoDaddy.com, LLC
abuse@godaddy.com
Google, LLC
Google-cloud-compliance@google.com
Content current as of:
06/22/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy
MARCS-CMS 547409 —
February 04, 2021
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Mark H. Mandel, PharmD
Recipient Title
Owner and Pharmacist-in-Charge
Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy
384 E. Irving Park Road
Roselle
,
IL
60172-2007
United States
Issuing Office:
Detroit District Office
United States
(313) 393-8100
Dear Dr. Mandel:
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 # 547409) dated February 27, 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
Director of Compliance
Division of Pharmaceutical Quality Operations III
Content current as of:
02/12/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Solace Technologies, LLC d/b/a Solace Vapor
MARCS-CMS 583029 —
April 09, 2021
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW1901096
Product:
Tobacco
Recipient:
Recipient Name
Brendan McDermott
Solace Technologies, LLC d/b/a Solace Vapor
2665 Park Center Drive Unit D
Simi Valley
,
CA
93065
United States
info@solacevapor.com
sales@solacevapor.com
Issuing Office:
Center for Tobacco Products
United States
Dear Brendan McDermott:
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 June 19, 2019 and June 23, 2019, in response to our Warning Letter dated June 7, 2019. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding the Instagram account of Pandora Blue (https://www.instagram.com/pandora.blue), the Facebook account of Pandora Blue (https://www.facebook.com/pandorablueee), and the Twitter account of Pandora Blue (https://twitter.com/pandora_pblive), containing social media posts with labeling and/or advertising for e-liquid products on behalf of Solace Vapor, as well as the website https://solacevapor.com, the Instagram account of Solace Vapor (https://www.instagram.com/solacevapor), and the Facebook account of Solace Vapor(https://www.facebook.com/solacevapor).
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
Attn: Azim Chowdhury
chowdhury@khlaw.com
Content current as of:
04/22/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Somalabs, Inc
MARCS-CMS 573299 —
August 11, 2021
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Dietary Supplements
Recipient:
Recipient Name
Roderick Egger
Recipient Title
President
Somalabs, Inc
102 Otis St. Ste 1a
Northborough
,
MA
01532-2415
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Dear Mr. Egger:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS # 573299, issued on May 31, 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 Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
08/13/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Soterion Development, Inc.
MARCS-CMS 586355 —
May 04, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Gilberto Cedeno
Recipient Title
General Manager/Owner
Soterion Development, Inc.
Avenue 2nd West, David
Pedregal
Chiriqui
Panama
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear: Mr. Cedeno:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 586355, issued August 19, 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/
Robyn R. Jones
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
05/12/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Sovereign Laboratories, LLC
MARCS-CMS 606490 —
August 21, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Douglas Wyatt
Sovereign Laboratories, LLC
70 Sheath Dr
Sedona
,
AZ
86336
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear: Mr. Douglas Wyatt,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our COVID-19 Warning Letter Re: 606490, issued June 15, 2020. Based on our evaluation, it appears you have addressed the violation(s) 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
Food and Drug Administration
cc:
HFS-605
CMS # 606490/ WA# 331763
FEI# 3014751882
Content current as of:
09/07/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Sparrow Health & Performance LLC
MARCS-CMS 608460 —
March 31, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Rebecca Rogers
Sparrow Health & Performance LLC
2000 Southlake Park
Suite 150
Hoover
,
AL
35244
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Ms. Rogers:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 608460, issued December 21, 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:
04/06/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Spectrum Laboratory Products, Inc.
MARCS-CMS 573311 —
June 24, 2021
Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs
Recipient:
Recipient Name
Russell Kneipp
Recipient Title
Chief Operating Officer
Spectrum Laboratory Products, Inc.
14422 S. San Pedro Street
Gardena
,
CA
90248-2027
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Mr. Kneipp:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #573311 and dated June 4, 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
Speedwinds Nutrition, Inc.
MARCS-CMS 609298 —
June 09, 2021
Delivery Method:
Overnight Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Clayton J. Montgomery
Recipient Title
President
Speedwinds Nutrition, Inc.
818 SW 3rd Avenue
Portland
,
OR
97204
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
Dear Mr. Montgomery:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter CMS 609298, dated December 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/
Miriam R. Burbach
District Director
Program Division Director
Office of Human and Animal Food
Operations – West Division 6
Content current as of:
06/28/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Sprout Pharmaceuticals, Inc.
MARCS-CMS 610569 —
March 15, 2021
Reference #:
NDA 022526
Product:
Drugs
Recipient:
Recipient Name
Cindy Eckert
Recipient Title
Chief Executive Officer
Sprout Pharmaceuticals, Inc.
4350 Lassiter at North Hills Avenue, #260
Raleigh
,
NC
27609
United States
Issuing Office:
The Office of Prescription Drug Promotion (OPDP)
United States
Dear Ms. Eckert:
The Food and Drug Administration has completed evaluation of Sprout Pharmaceuticals corrective actions in response to our Warning Letter dated August 31, 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 241 in addition to the NDA number in all future correspondence relating to this particular matter.
Sincerely,
{See appended electronic signature page}
Jina Kwak, PharmD, RAC
Regulatory Review Officer
Division of Advertising & Promotion Review 2
Office of Prescription Drug Promotion
CC: Nicol George, Pharm.D.
Executive Director, Regulatory & Medical Review Services
OneSource Regulatory LLC
P.O. Box 1047
Libertyville, IL 60048
--------------------------------------------------------------------------------------------
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/
------------------------------------------------------------
JINA KWAK
03/15/2021 03:07:47 PM
Content current as of:
03/22/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Sprouts Unlimited Wholesale Foods Inc
MARCS-CMS 603883 —
April 30, 2021
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. William C. Beach
Recipient Title
Owner
Sprouts Unlimited Wholesale Foods Inc
799 51st St.
Marion
,
IA
52302-3857
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
Dear Mr. Beach:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 603883) on February 21, 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/
Matthew R. Sleeter
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
05/12/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Square Vape Labs Inc.
MARCS-CMS 613512 —
July 09, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101516
Product:
Tobacco
Recipient:
Recipient Name
Anthony Napolitano
Square Vape Labs Inc.
United States
admin@squarevapelabs.com
info@squarevapelabs.com
Issuing Office:
Center for Tobacco Products
United States
Dear Anthony Napolitano:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your email dated March 6, 2021 in response to our Warning Letter dated February 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 https://squarevapelabs.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:
Domains By Proxy, LLC
squarevapelabs@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
Content current as of:
07/21/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Stason Pharmaceuticals, Inc.
MARCS-CMS 604889 —
June 24, 2021
Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs
Recipient:
Recipient Name
Harry T. Fan
Recipient Title
Chief Executive Officer
Stason Pharmaceuticals, Inc.
11 Morgan
Irvine
,
CA
92618
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
949-608-2900
Dear Mr. Fan:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #604889 and dated July 8, 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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
07/07/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Sugar Vapor Company
MARCS-CMS 613082 —
June 23, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
RW2101487
Product:
Tobacco
Recipient:
Recipient Name
Ryon Calhoun
Sugar Vapor Company
United States
ryoncalhoun@yahoo.com
admin@sugarvapor.net
Issuing Office:
Center for Tobacco Products
United States
Dear Ryon Calhoun:
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 February 22, 2021 and March 12, 2021, in response to our Warning Letter dated February 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.sugarvapor.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 Johnson
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
eNom, LLC
abuse@enom.com
Google LLC
Google-cloud-complance@google.com
Content current as of:
06/28/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Sugiyo U.S.A., Inc.
MARCS-CMS 607399 —
December 28, 2021
Delivery Method:
Certified Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Susan M. Ruiz
Recipient Title
President
Sugiyo U.S.A., Inc.
P. O. Box 468
Anacortes
,
WA
98221
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
Dear Ms. Ruiz:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 607399 dated July 15, 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
Content current as of:
01/04/2022
Regulated Product(s)
Food & Beverages