tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Losurdo Foods, Inc.
MARCS-CMS 427983 —
December 19, 2018
Delivery Method:
United Parcel Service
Recipient:
Recipient Name
Marc J.X. Losurdo
Recipient Title
Chief Executive Officer
Losurdo Foods, Inc.
Losurdo Foods, Inc.
20 Owens Road
Hackensack
,
NJ
07601
United States
Issuing Office:
Public Health Service
158-15 Liberty Avenue
Jamaica
,
NY
11433
United States
Dear Mr. Losurdo:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2014-60, issued on September 22, 2014. 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 M. Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
02/01/2019
CLOSEOUT LETTER
Louisville Reproductive Center
MARCS-CMS 533267 —
March 05, 2018
Recipient:
Louisville Reproductive Center
United States
Issuing Office:
United States
Office of Biological Products Operations
Division II Compliance Branch
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
March 05, 2018
Robert J. Homm, MD
Medical Director
Louisville Reproductive Center
Louisville, KY 40207-4733
Dear Dr. Homm,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, WL #OBPO 17-03 issued August 29, 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/
Dan Cline Captain, USPHS (Ret)
Compliance Officer
U.S. Food and Drug Administration
Office of Biological Products Operations
Division II, Compliance Branch
Tel:
949-608-4433
Daniel.Cline@fda.hhs.gov
Content current as of:
03/27/2018
CLOSEOUT LETTER
Lupa Gourmet, Inc.
MARCS-CMS 492718 —
December 03, 2018
Recipient:
Recipient Name
Paolo Mannoni
Recipient Title
President
Lupa Gourmet, Inc.
Lupa Gourmet, Inc.
657 37th Street
Union City
,
NJ
07087-2514
United States
Issuing Office:
Office of Human and Animal Food Operations East Division I
United States
Dear Mr. Mannoni:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2016-30 dated March 21, 2016. 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East – Division 1
Content current as of:
12/10/2018
CLOSEOUT LETTER
m4 Nutrition Companies LLC
MARCS-CMS 491534 —
January 26, 2018
Recipient:
m4 Nutrition Companies LLC
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
January 26, 2018
Mathew W. Maynard
M4 Nutrition Companies, LLC
7324 Gaston Ave Ste 124-422
Dallas, TX 75214-6126
Dear: Mr. Maynard,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Re: 491534, 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/
Latasha A. Robinson, M.S.
Branch Chief
Dietary Supplement Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
01/31/2018
CLOSEOUT LETTER
Magadoo Corporation Co., Ltd.
MARCS-CMS 538124 —
February 07, 2018
Recipient:
Magadoo Corporation Co., Ltd.
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
February 7, 2018
Mr. Jaren Srichanil
Magadoo Corporation Co., LTD
201 Rangsit-Nakornnayok Co., LTD
201 Rangsit-Nakornnayok 33 Road
T.Prachathipat
Thanyaburi, Pathum Thani, 122130
Thailand
Dear Mr. Srichanil:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #538124 dated October 6, 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/
Robyn R. Jones
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Content current as of:
02/27/2018
CLOSEOUT LETTER
Mark Northcutt
MARCS-CMS 501198 —
April 26, 2018
Recipient:
Mark Northcutt
United States
Issuing Office:
United States
Office of Human and Animal Food –
West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100
April 26, 2018
DELIVERY VIA UPS
WARNING LETTER CLOSE-OUT LETTER
Mark Northcutt, Owner
33436 Highway 19
Laddonia, MO 63352
Dear Mr. Northcutt:
The Food and Drug Administration has completed an evaluation of Mark Northcutt corrective actions in response to our Warning Letter (CMS case #: 501198) on July 22, 2016. 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 A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
07/31/2018
CLOSEOUT LETTER
McGuff Compounding Pharmacy Services, Inc.
MARCS-CMS 481444 —
August 17, 2018
Recipient:
McGuff Compounding Pharmacy Services, Inc.
United States
Issuing Office:
United States
Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road,Irvine, CA 92612-2506
Telephone:
949-608-2900
Fax:
949-608-4417
August 17, 2018
Ronald M. McGuff, President/CEO
McGuff Compounding Pharmacy Services, Inc.
2921 West MacArthur Blvd., Suite 142
Santa Ana, CA 92704-7944
Dear Mr. McGuff:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL# 6-16) dated November 13, 2015. From May 25, 2017, to June 2, 2017, an FDA investigator conducted an inspection of your facility, McGuff Compounding Pharmacy Services, Inc., located at 2921 West MacArthur Blvd., Suite 142, Santa Ana, CA 92704-7944.  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 assure 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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
09/17/2018
CLOSEOUT LETTER
Mega Pro International
MARCS-CMS 527374 —
August 31, 2018
Recipient:
Mega Pro International
United States
Issuing Office:
United States
U.S. Food and Drug Administration
6th Ave & Kipling St, DFC Bldg 20
PO Box 25087
Denver, CO 8022-0087
August 31, 2018
VIA UPS OVERNIGHT
David V. Smith, Owner
Mega-Pro Nutrition, Inc.
251 Hilton Drive
St George, UT 84 790
Dear Mr. Smith:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter HAF4W(DEN)-17-17-WL dated August 25, 2017. 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/
LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Food Operations -
Division IV West
Content current as of:
09/11/2018
CLOSEOUT LETTER
Merges, Brian J
MARCS-CMS 519383 —
April 05, 2018
Recipient:
Merges, Brian J
United States
Issuing Office:
United States
Office of Human and Animal Food- West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100
April 5, 2018
DELIVERY VIA UPS
WARNING LETTER CLOSE-OUT LETTER
Mr. Brian J. Merges
7777 Old Highway Road
Peosta, IA 52068
CMS Case: 519383
Dear Mr. Merges:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 519383) on March 17, 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
Content current as of:
04/11/2018
CLOSEOUT LETTER
Metro Vapors, LLC
MARCS-CMS 562955 —
November 14, 2018
Delivery Method:
UPS and Electronic Mail
Recipient:
Recipient Name
Brandon Parrish
Metro Vapors, LLC
Metro Vapors, LLC
403 S. Highway 78
Wylie
,
TX
75098-3964
United States
info@metrovaporshop.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Brandon Parrish:
On September 12, 2018, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Candy King Sour Worms e-liquid product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because its labeling and/or advertising is false or misleading. Specifically, FDA determined that the labeling and/or advertising of your Candy King Sour Worms e-liquid is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.
On October 1, 2018, you sent FDA a response to the Warning Letter, and we held a teleconference on November 8, 2018 to discuss the Warning Letter and your response. In response to the Warning Letter, you stated that you implemented corrective actions to address the violation identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violation identified in the Warning Letter.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C 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.
Should you have any questions or concerns, please contact me at (301 ) 796-9235 or by email at elenita.
ibarrapratt@fda
. hhs.qov.
Sincerely,
/S/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
cc:
Azim Chowdhury
Keller and Heckman LLP
1001 G Street NW, Suite 500 West
Washington, DC 20001
chowdhury@khlaw.com
Brandon Parrish
5736 Highway 78 Suite A
Sachse, TX 75048
Domains by Proxy, LLC
metrovaporshop.com@domainsbyproxy.com
GoDaddy.com, LLC
abuse@godaddy.com
BigCommerce Inc.
abuse@bigcommerce.com
Content current as of:
03/04/2019
CLOSEOUT LETTER
Miami Fat Supply, Inc
MARCS-CMS 485740 —
January 19, 2018
Recipient:
Miami Fat Supply, Inc
United States
Issuing Office:
United States
Florida District Office
555 Winderley Place #200
Maitland, FL 32751
Telephone:
(407) 475-4700
VIA ELECTRONIC MAIL
mark@miamifatsupply.com
January 19, 2018
Mr. D. Mark Jordan, President
Miami Fat Supply, Inc.
1510 Max Hooks Road, #F
Groveland, Florida 34736 U.S.A.
RE: Warning Letter Close-Out Letter – FEI 3008872140
CMS Case ID: 485740, CMS WA ID: 182270
Dear Mr. Jordan:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter FLA-16-12, dated March 17, 2016. 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/
Kathleen M. Sinninger
Acting Program Division Director
Division of Medical Devices and
Radiological Health Operations II Central
Content current as of:
01/23/2018
CLOSEOUT LETTER
Middle East Bakery, Inc.
MARCS-CMS 433344 —
October 15, 2018
Delivery Method:
United Parcel Service
Recipient:
Recipient Name
Joseph J. Boghos
Recipient Title
President
Middle East Bakery, Inc.
Middle East Bakery, Inc.
30 International Way
Lawrence
,
MA
01843
United States
Issuing Office:
New England District Office
One Montvale Avenue, 4th floor
Stoneham
,
MA
02180
United States
Dear Mr. Boghos:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS 433344, September 18, 2014]. 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/
CDR Catherine M. Beer
Director of Compliance
Office of Human and Animal Food Operations
East – Division 1
Content current as of:
10/30/2018
CLOSEOUT LETTER
Montana Emu Ranch Company Inc
MARCS-CMS 509205 —
January 31, 2018
Recipient:
Montana Emu Ranch Company Inc
United States
Issuing Office:
United States
Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021
January 31 , 2018
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Penelope S. Collins, Owner
Montana Emu Ranch Company
P.O. Box 7041
Kalispell, Montana 59904
Dear Ms. Collins:
The Food and Drug Administration has completed an evaluation of your firm 's corrective actions in response to our Warning Letter SEA 17-11 dated April 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/
Miriam R. Burbach
Program Division Director
District Director
Content current as of:
09/18/2018
CLOSEOUT LETTER
Moy-Fincher Medical Group
MARCS-CMS 440852 —
February 08, 2018
Recipient:
Moy-Fincher Medical Group
United States
Issuing Office:
United States
5001 Campus Drive
College Park, MD 20740
FEB 8, 2018
Ronald L. Moy
DNA EGF Renewal
421 N. Rodeo Dr. Suite T-7
Beverly Hills, CA 90210
Dear Mr. Moy:
The Food and Drug Administration has completed an evaluation of your firm 's corrective actions in response to our Warning Letter #440852 issued February 12, 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 Jetter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Latasha A. Robinson
Branch Chief
Dietary Supplements & Labeling Assessment Branch
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
02/13/2018
CLOSEOUT LETTER
MS Fruit & Vegetable Co., LLC
April 03, 2018
Recipient:
MS Fruit & Vegetable Co., LLC
United States
Issuing Office:
United States
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
April 3, 2018
Lindsey B. Mabry and Lee D. Boone, Co-Owners
MS Fruit & Vegetable Co., LLC
364 Sunset Loop
Grenada, Mississippi 38901-4517
Dear Ms. Mabry and Mr. Boone:
The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 520207. 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/
Kimberly A. Dutzek
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East
Content current as of:
04/11/2018
CLOSEOUT LETTER
Mylan Laboratories Limited, (Nashik FDF)
July 18, 2018
Recipient:
Mylan Laboratories Limited, (Nashik FDF)
United States
Issuing Office:
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
July 18, 2018
Mr. Rajiv Malik
President
Mylan Pharmaceuticals, Inc.
1000 Mylan Boulevard
Canonsburg, PA 15317
Reference: FEI 3005587313
Dear Mr. Malik:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-32 dated March 31, 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 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 violations be observed during a subsequent inspection or through other means,
Sincerely,
/S/
Joseph Lambert
Compliance Officer
Division of Drug Quality I
Content current as of:
08/06/2018