tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Lehman Family Farms, Inc. dba Home Grown Cellars
MARCS-CMS 480589 —
April 20, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Alexander F. Lehman
Recipient Title
CEO
Lehman Family Farms, Inc. dba Home Grown Cellars
13702 Road 20
Madera
,
CA
93637-9222
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Mr. Lehman:
The Food and Drug Administration has completed an evaluation of (your/your firm’s) corrective actions in response to our Warning Letter dated December 2, 2015. 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
04/27/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Les Produits Chimiques B.G.R., Inc.
MARCS-CMS 542247 —
May 21, 2020
Reference #:
320-18-64
Product:
Drugs
Recipient:
Recipient Name
Ms. Nathalie A. Bélanger
Recipient Title
Vice-President and Owner
Les Produits Chimiques B.G.R., Inc.
600 Avenue Delmar
Pointe-Claire
QC
H9R 4A8
Canada
Issuing Office:
Division of Drug Quality II
United States
Dear Ms. Bélanger:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-18-64 dated July 23, 2018.
Based on our evaluation, it appears that you have adequately addressed the deviations 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 FDA 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 deviations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Bill Fowler
Compliance Officer
Division of Drug Quality II
Content current as of:
05/21/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Leventon S. A. U.
MARCS-CMS 560534 —
February 28, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Francesc Cuxart
Recipient Title
CEO
Leventon S. A. U.
Newton 18-2
Sint Esteve Sesrovires
08635
Barcelona
Spain
Issuing Office:
Division of Health Technology 3C
United States
Dear Mr. Cuxart:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (WL) dated September 5, 2018. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this WL.
This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Tina Kiang, Ph. D
Director
Division of Drug Delivery and General
Hospital Devices and Human Factors
Office of Gastrorenal, ObGyn, General
Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
03/04/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Line One Nutrition, Inc
MARCS-CMS 491535 —
June 18, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
Andrew Dean Mc Michael
Recipient Title
President
Line One Nutrition, Inc
105 Tradesman Dr. Ste B
Hutto
,
TX
78634-4131
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Mc Michael:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Re: 491535, issued March 31, 2016. 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
Content current as of:
06/29/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
M Dialysis AB
MARCS-CMS 554169 —
July 01, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Olof Nord
Recipient Title
CEO
M Dialysis AB
Hammarby Fabriksvag 43
120 33
Stockholms Lan
Sweden
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Olof Nord:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 554169, dated June 6, 2018). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely yours,
/S/
for Carlos Peña, Ph.D., M.S. Director
Office of Health Technology 5 (OHT5): Office of
Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality (OPEQ)
Center for Devices and Radiological Health (CDRH)
CC:
Kelly Nashawaty 73 Princeton Street
#302
North Chelmsford, MA 01863 Olof.nord@mdialysis.se
Content current as of:
05/09/2022
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Malata African & Caribbean Market
MARCS-CMS 485911 —
March 03, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Edward Siaw, Dilys Wireko
Recipient Title
Co-Owners
Malata African & Caribbean Market
185 McClellan Street
Bronx
,
NY
10456
United States
Issuing Office:
Division of Northeast Imports-Compliance Branch
United States
Dear Mr. Siaw and Ms. Wireko,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2016-17, dated December 30, 2015. 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/
Slater Bartlett
Compliance Officer
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration
Content current as of:
03/04/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Mannatech Incorporated
MARCS-CMS 521321 —
January 03, 2020
Delivery Method:
VIA UPS
Reference #:
2018-DAL-WL-2
Product:
Dietary Supplements
Recipient:
Recipient Name
Alfredo Bala
Recipient Title
President
Mannatech Incorporated
600 South Royal Lane
Coppell
,
TX
75019
United States
Issuing Office:
Office of Human and Animal Food-West Div. 3
United States
214-253-5200
Dear Mr. Bala:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (2018-DAL-WL-2) issued on November 14, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Casey Hamblin
Recall Coordinator/Compliance Officer
Office of Human and Animal Food-West Div. 3
Content current as of:
01/06/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Manns Fish Market
MARCS-CMS 525533 —
August 19, 2020
Delivery Method:
VIA UPS
Recipient:
Recipient Name
Byron A. Mann
Recipient Title
Co-Owner
Manns Fish Market
2010 E. 7th St.
Caruthersville
,
MO
63830
United States
Issuing Office:
Kansas City District Office
United States
913-495-5100
Dear Mr. Mann:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 525533) on June 20, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Andrew A. Hoopes
Compliance Officer
Office of Human and Animal Food-West Div. 2
CC:
John A. Mann, Co-Owner
1249 E. 20th St.
Caruthersville, MO 63830
Content current as of:
08/21/2020
CLOSEOUT LETTER
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
MARCS-CMS 560736 —
February 20, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Omar S. Ishrak
Recipient Title
Chief Executive Officer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
710 Medtronic Parkway
Minneapolis
,
MN
55432
United States
Issuing Office:
Office of Medical Device and Radiological Health Operations Division 2
United States
(407) 475-4700
Dear Mr. Ishrak:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 560736. 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/
Timothy G. Philips
Compliance Officer
Office of Medical Device and Radiological Health Operations (OMDRHO)
Division 2 – Central
Minneapolis District
Content current as of:
02/27/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Medtronic Puerto Rico Operations Co.
MARCS-CMS 562437 —
February 20, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Omar S. Ishrak
Recipient Title
Chief Executive Officer
Medtronic Puerto Rico Operations Co.
710 Medtronic Parkway
Minneapolis
,
MN
55432
United States
Issuing Office:
Office of Medical Device and Radiological Health Operations Division 2
United States
(407) 475-4700
Dear Mr. Ishrak:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 562437. 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/
Timothy G. Philips
Compliance Officer
Office of Medical Device and Radiological Health Operations (OMDRHO)
Division 2 – Central
Minneapolis District
Content current as of:
02/27/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Merchants Market St. Croix LLC
MARCS-CMS 575447 —
March 13, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
19-HAFE4-WL-05
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Rick Wilson
Recipient Title
President
Merchants Market St. Croix LLC
4000 Estate Diamond
Christiansted
St Croix
,
VI
00820
United States
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
(787) 729-8500
Dear Mr. Wilson:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 19-HAFE4-WL-05 dated March 11, 2019. 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:
03/20/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Metuchen Pharmaceuticals, LLC
MARCS-CMS 590713 —
September 18, 2020
Reference #:
NDA 202276
Product:
Drugs
Recipient:
Recipient Name
Fady Boctor
Metuchen Pharmaceuticals, LLC
200 US Hwy 9 Suite 500
Manalapan
,
NJ
07726
United States
Issuing Office:
Office of Prescription Drug Promotion
United States
Dear Mr. Boctor:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated August 16, 2019. 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 169, 182, 187 in addition to the NDA number in all future correspondence relating to this particular matter.
Sincerely,
{See appended electronic signature page}
Elvy Varghese, PharmD
Regulatory Review Officer
Division of Advertising & Promotion Review 2
Office of Prescription Drug Promotion
Cc: Nicol George, PharmD
Executive Director, Regulatory & Medical Review Services
OneSource Regulatory LLC
PO 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/
------------------------------------------------------------
ELVY M VARGHESE
09/18/2020 10:03:33 AM
Content current as of:
03/11/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Mind, Body & Coal LLC
MARCS-CMS 593774 —
December 21, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
Lisa Smith
Recipient Title
CEO
Mind, Body & Coal LLC
2920 Bayshore Vista Drive
Tampa
,
FL
33611
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mrs. Smith:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #593774, issued 07/23/20. 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,
Carrie Lawlor
/S/
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Cc:
Jessica S. West | Shumaker
Attorney at Law
Bank of America Plaza, Suite 2800
101 East Kennedy Boulevard | Tampa, FL 33602
Content current as of:
05/12/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
MistVapor USA
MARCS-CMS 610014 —
November 02, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
RW2001407
Product:
Tobacco
Recipient:
MistVapor USA
United States
service@mistvapor.com
Issuing Office:
Office of Compliance and Enforcement
United States
Dear Sir or Madam:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated August 14, 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://mistvapor.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
Content current as of:
12/01/2020
Regulated Product(s)
Tobacco
CLOSEOUT LETTER
Montes Tortilla Factory
MARCS-CMS 541060 —
February 12, 2020
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Dahlia Rodriguez
Recipient Title
Owner
Montes Tortilla Factory
7536 North FM 88
Weslaco
,
TX
78599
United States
Issuing Office:
Office of Human and Animal Food-West Division 3
United States
214-253-5200
Dear Ms. Rodriguez:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case 541060) issued on November 14, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Casey Hamblin
Recall Coordinator/Compliance Officer
Office of Human and Animal Food-West Div. 3
Content current as of:
02/18/2020
Regulated Product(s)
Food & Beverages