tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Jojo’s Smokeless World Inc. d/b/a The Mod Shield
MARCS-CMS 613210 —
June 23, 2021
Delivery Method:
Electronic Mail
Reference #:
RW2101491
Product:
Tobacco
Recipient:
Recipient Name
Maan Yousef
Jojo’s Smokeless World Inc. d/b/a The Mod Shield
United States
kafrounmaan@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Maan Yousef:
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 received by FDA, on February 24, 2021 and March 18, 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 violation contained in the Warning Letter regarding your website https://www.themodshield.com.
However, since 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 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:
Jojo's OH-10 Vapes
Jojospinners@gmail.com
Returns@ModShieldByJojo.com
Domain.com, LLC
compliance@domain-inc.net
Shopify, Inc.
abuse@shopify.com
Content current as of:
07/19/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Laboratorios Dentales De Zona Franca, S.A.
MARCS-CMS 607719 —
August 20, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Mr. James R. Glidewell
Recipient Title
President and Chief Executive Officer
Laboratorios Dentales De Zona Franca, S.A.
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine
,
CA
92612
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Glidewell:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #607719, dated May 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 yours,
/S/
Michael E. Adjodha, M.ChE.
Assistant Director
Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Herbert Schoenhoefer
Director of Regulatory Affairs and Quality Assurance
U.S. Agent for Laboratorios Dentales De Zona Franca, S.A.
Prismatik Dentalcraft Inc.
2144 Michelson Dr.
Irvine, CA 92612
Content current as of:
09/22/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Lianyungang Aikang Food Co., Ltd
MARCS-CMS 593495 —
February 04, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Chuanai Li
Recipient Title
President
Lianyungang Aikang Food Co., Ltd
118 Qianjin South Road, Chaoyang Town, Development Zone
Lianyungang Shi
Jiangsu Sheng
,
222068
China
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear: Mr. Li:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 593495, issued December 4, 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:
02/12/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Lipotriad LLC
MARCS-CMS 612206 —
November 22, 2021
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Kenneth Krieg
Recipient Title
CEO
Lipotriad LLC
5 Sentry Parkway East
Suite 210
Blue Bell
,
PA
19422
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
Dear Mr. Krieg:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued to Lipotriad LLC on March 19, 2021. 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:
12/13/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
LNK International, Inc.
MARCS-CMS 582253 —
December 01, 2021
Delivery Method:
READ/DELIVERY RECEIPT
Product:
Drugs
Recipient:
Recipient Name
Mr. Pankaj S. Chudgar
Recipient Title
President
LNK International, Inc.
22 Arkay Dr
Hauppauge
,
NY
11788
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Dear Mr. Chudgar:
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 #582253], dated September 26, 2019. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter.
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.
Respectfully,
/S/
Diana Amador-Toro
Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District
Content current as of:
12/14/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
The Mad Alchemist LLC
MARCS-CMS 612962 —
June 04, 2021
Delivery Method:
UPS ans Electronic Mail
Reference #:
RW2101472
Product:
Tobacco
Recipient:
Recipient Name
Nicole Pennington
The Mad Alchemist LLC
119 Childers Drive
London
,
KY
40741
United States
info@alchemistvapeshop.com
Issuing Office:
Center for Tobacco Products
United States
Dear Nicole Pennington:
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 March 1, 2021, in response to our Warning Letter dated January 29, 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.alchemistvapeshop.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 and Electronic Mail
cc:
The Mad Alchemist
Attn: Nicole Pennington
85 Dogwood Trail
London, KY 40741
The Mad Alchemist LLC
Attn: Nicole Pennington
1960 County Farm Rd
London, KY 40741
GoDaddy.com, LLC
abuse@godaddy.com
Wix.com, Inc.
abuse@wix.com
Content current as of:
06/08/2021
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Magellan Diagnostics, Inc.
MARCS-CMS 532743 —
August 03, 2021
Delivery Method:
Via Email
Product:
Medical Devices
Recipient:
Recipient Name
John (Jack) P. Kenny
Recipient Title
CEO
Magellan Diagnostics, Inc.
Meridian Bioscience
3471 Riverhills Dr.
Cincinnati
,
OH
45244
United States
jack.kenny@meridianbioscience.com
Issuing Office:
New England District Office
United States
Dear Mr. Kenny:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #532743) issued on October 23, 2017, at Magellan Diagnostics, Inc., 101 Billerica Avenue, Building 4, North Billerica, Massachusetts, FEI 1218996. 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 yours,
/S/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health
Division-1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
08/06/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Manhattan Stitching Company, Inc.
MARCS-CMS 611719 —
September 27, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Cory Jachnuk
Manhattan Stitching Company, Inc.
8362 Artesia Boulevard
Suite E
Buena Park
,
CA
90621
United States
cory@manhattanstiching.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Jachnuk:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 611719, August 13, 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
Marathon Ventures, Inc.
MARCS-CMS 585719 —
March 04, 2021
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
John S. Larsen/Michael P. Sortino
Recipient Title
President/Co-Owner, Co-Owner
Marathon Ventures, Inc.
901 Fort Crook Rd N
Bellevue
,
NE
68005-4335
United States
Issuing Office:
Office of Human and Animal Food – Division II West
United States
913-495-5100
Dear Messrs. Larsen and Sortino:
The Food and Drug Administration has completed an evaluation of Marathan Ventures Inc. corrective actions in response to our Warning Letter (CMS case #: 585719) on November 14, 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/
Miguel Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
03/11/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Mario Hidalgo DBA Distribuidora de Productos Alimenticios El Paisita
MARCS-CMS 614478 —
December 09, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mario Hidalgo
Mario Hidalgo DBA Distribuidora de Productos Alimenticios El Paisita
7404 N 34th St.
Mcallen
,
TX
78504-4974
United States
Issuing Office:
Division of Southwest Imports
United States
214-253-5255
Dear Mr. Mario Hidalgo,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter Ref: CMS 614478 dated July 21, 2021. Based on our evaluation of the current follow-up inspection, it appears that you have addressed the violations brought to your attention in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy, effectiveness, and sustainability of the corrections you have made.
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 promogulated regulations or with other relevant FDA legal authority. The Agency will continue to monitor your state of compliance with the FDA regulations applicable to your industry type. This letter will not preclude any future regulatory action should violations of such regulations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Toby H. Hill,
DSWI Compliance Officer
Content current as of:
02/01/2022
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Masa NY, LLC
MARCS-CMS 539271 —
November 30, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Masayoshi Takayama/Ms. Catherine Takayama
Recipient Title
Partner
Masa NY, LLC
10 Columbus Circle, 401
New York
,
NY
10019-1158
United States
Issuing Office:
New York District Office
United States
Dear Mr. Takayama & Ms. Takayama:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 539271 dated October 16, 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
Director, Compliance Branch
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration
Content current as of:
12/14/2021
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Mask Supply Store
MARCS-CMS 612585 —
September 27, 2021
Product:
Medical Devices
Recipient:
Mask Supply Store
1 Linden Place
Suite 303
Great Neck
,
NY
11021
United States
info@masksupply.store
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 # 612585, May 21, 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:
10/05/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Medlife Pharmacy and Compounding, Inc.
MARCS-CMS 607417 —
November 29, 2021
Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Shar Eshraghi, Pharm.D.
Medlife Pharmacy and Compounding, Inc.
6644 Irvine Center Dr.
Irvine
,
CA
92618
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Dr. Eshraghi:
The U.S. Food and Drug Administration has completed an evaluation of your corrective actions in response to our warning letter (Ref CMS 607417) dated April 24, 2020. 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 the 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:
12/14/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Mikart LLC
MARCS-CMS 605071 —
November 17, 2021
Delivery Method:
TRANSMITTED BY FACSIMILE
Reference #:
ANDA 040776
Product:
Drugs
Recipient:
Recipient Name
Stefano Antonsson
Recipient Title
CEO
Mikart LLC
Outlook Pharmaceuticals, Inc.
8044 Montgomery Road
Suite 700
Cincinnatti
,
OH
45236
United States
Issuing Office:
The Office of Prescription Drug Promotion (OPDP)
United States
Dear Mr. Antonsson:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated February 21, 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 60 in addition to the ANDA number in all future correspondence relating to this particular matter.
Sincerely,
{See appended electronic signature page}
Domenic D’Alessandro, PharmD, MBA, BCPS
Regulatory Review Officer
Division of Advertising & Promotion Review 1
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.
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/s/
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Content current as of:
12/13/2021
Regulated Product(s)
Drugs