tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Farmers Ranchers Coop Assn
MARCS-CMS 559583 —
March 25, 2019
Delivery Method:
UPS
Recipient:
Recipient Name
Cindie Kesler
Recipient Title
CEO/President
Farmers Ranchers Coop Assn
224 S. Main Street
Ainsworth
,
NE
69210
United States
Issuing Office:
Center for Veterinary Medicine
8050 Marshall Drive
Suite 205
Lenexa
,
KS
66214-1524
United States
913-495-5100
Dear Ms. Kesler:
The Food and Drug Administration has completed an evaluation of Farmers/Ranchers Cooperative Association Ainsworth corrective actions in response to our Warning Letter (CMS case #: 559583) on October 5, 2018. 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:
03/28/2019
CLOSEOUT LETTER
Farmo Foods, Inc.
MARCS-CMS 471175 —
April 02, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Farhad Hariri
Recipient Title
President
Farmo Foods, Inc.
2031 2nd Street
Berkeley
,
CA
94710
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Farhad Hariri:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 471175), dated November 18, 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/
for/
Sergio Chavez, Director of Compliance
Office Human and Animal Foods
Division West 5
Content current as of:
04/11/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Fehling Instruments GmbH & Co. KG
MARCS-CMS 479523 —
August 21, 2019
Product:
Medical Devices
Recipient:
Recipient Name
Gerald Fehling
Recipient Title
CEO
Fehling Instruments GmbH & Co. KG
Hanauer Landstr. 7
63791
Karlstein a. Main
Germany
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Fehling:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 479523, dated October 13, 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 yours,
/S/
Bram Zuckerman, MD
Director
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
08/28/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Flayco Products, Inc.
MARCS-CMS 534460 —
December 10, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
20-HAFE4-WLCOL-01
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jorge Astorquiza Sr.
Recipient Title
President
Flayco Products, Inc.
4823 N. Hale Ave.
Tampa
,
FL
33614-6517
United States
Issuing Office:
Office of Human and Animal Feed Operations East Division IV
United States
(787) 729-8500
Dear Mr. Astorquiza:
The Food and Drug Administration has completed an evaluation of your
firm’s
corrective actions in response to Warning Letter
17-OHAFOEDIV4-WL-08
dated August 18, 2017. 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
Office of Human and Animal Feed Operations, East Division IV
Content current as of:
12/19/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Forbiddenlabz
MARCS-CMS 576998 —
June 17, 2019
Recipient:
Recipient Name
Kristoffer Spencer
Recipient Title
Owner
Forbiddenlabz
520 Fremont Street
Monterey
,
CA
93940
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Spencer:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS # 576998, dated April 10, 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/
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:
03/20/2020
CLOSEOUT LETTER
Fox Ridge Farm, Inc. DBA Wilsons Orchard
MARCS-CMS 510892 —
February 26, 2019
Delivery Method:
UPS
Recipient:
Recipient Name
Paul L. Rasch
Recipient Title
President/Co-Owner
Fox Ridge Farm, Inc. DBA Wilsons Orchard
Fox Ridge Farm, Inc. DBA Wilsons Orchard
1998 Poplar Ave NE
Solon
,
IA
52333
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
913-495-5100
Dear Mr. Rasch:
The Food and Drug Administration has completed an evaluation of Fox Ridge Farm, Inc., dba Wilsons Orchard corrective actions in response to our Warning Letter (CMS Case #: 510892) on February 5, 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/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
03/11/2019
CLOSEOUT LETTER
Gasco Industrial
MARCS-CMS 489096 —
May 30, 2019
Delivery Method:
UPS NEXT DAY DELIVERY
Reference #:
16-SJN-WL-06
Product:
Food & Beverages
Recipient:
Recipient Name
Dan Sigman
Recipient Title
Owner
Gasco Industrial
Rincon Industrial Park
Calle A, Lote 3
Gurabo
00778
Puerto Rico
Issuing Office:
Center for Food Safety and Applied Nutrition
466 Fernandez Juncos Avenue
San Juan
00901
Puerto Rico
Dear Mr. Sigman:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter 16-SJN-WL-06, dated February 11, 2016. 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:
05/31/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Gold Crown Natural Products
MARCS-CMS 566223 —
June 04, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Arnaldo Arias
Gold Crown Natural Products
12211 SW 121st Terr
Miami
,
FL
33186
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Arias:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 566223, issued February 5, 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/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
06/06/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Gold State Nut
MARCS-CMS 461313 —
April 03, 2019
Delivery Method:
United States Postal Service
Product:
Food & Beverages
Recipient:
Recipient Name
Gregory J. Banes
Recipient Title
Co-Owner
Gold State Nut
P.O. Box 1093
Biggs
,
CA
95917-9798
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Banes:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated November 10, 2015. 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/
Robert B. Mcnab
Acting Director, Compliance Branch
Food and Drug Administration
HAF Division West 5
Content current as of:
04/11/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
H & W Farms LLC
MARCS-CMS 518122 —
October 10, 2019
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Timothy E. Heffron
Recipient Title
President
H & W Farms LLC
13375 Belding Road, NE
Belding
,
MI
48809-9383
United States
Issuing Office:
Office of Human and Animal Food Division East 6
550 W. Jackson Blvd
Suite 1500
Chicago
,
IL
60661
United States
(312) 353-5863
Dear Mr. Heffron,
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (2017-DET-03, dated March 22, 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/
Byron Ho, DVM
Compliance Officer
Office of Human and Animal Food
Division East 6
Content current as of:
10/11/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Hangzhou Facecare Cosmetics Co., Ltd.
MARCS-CMS 537146 —
June 28, 2019
Product:
Drugs
Recipient:
Recipient Name
John Wu
Recipient Title
General Manager
Hangzhou Facecare Cosmetics Co., Ltd.
No. 755 Yinhai Road
HEDA
Hangzhou Shi
Zhejiang Sheng
,
310018
China
Issuing Office:
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Wu:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 320-18-09 dated November 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 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/
Bryce Hammer
Compliance Officer
Global Compliance Branch IV
Division of Drug Quality II
CDER/OC/OMQ
Content current as of:
07/17/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Hanna's Herb Shop
MARCS-CMS 569309 —
November 25, 2019
Delivery Method:
UPS Overnight
Reference #:
HAF4W(DEN)-19-06-WL
Product:
Dietary Supplements
Recipient:
Recipient Name
Thomas M. Brown
Recipient Title
President
Hanna's Herb Shop
5684 Valmont Rd
Boulder
,
CO
80301
United States
Issuing Office:
Office of Human and Animal Food Operations Division IV West
United States
Dear Mr. Brown:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter HAF4W(DEN)-19-06-WL, dated March 5, 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/
LaTonya M. Mitchell, PhD
Program Division Director
Office of Human and Animal Food Operations -
Division IV West
Content current as of:
12/09/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Hans Zipperle, S.p.A.
MARCS-CMS 501342 —
November 13, 2019
Product:
Food & Beverages
Juice
Recipient:
Recipient Name
Thomas Brandstaetter
Recipient Title
Managing Director
Hans Zipperle, S.p.A.
Via Max-Valier, 3, C.P. 238
39012
Merano
BZ
Italy
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Brandstaetter:
The Food and Drug Administration (FDA) conducted a follow-up inspection of your manufacturing facility to evaluate your firm’s corrective actions in response to our Warning Letter #501342, issued September 7, 2016. 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 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/
Maria Corpuz
Team Leader
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
11/19/2019
Regulated Product(s)
Food & Beverages
Juice
CLOSEOUT LETTER
Healthy Healing Enterprises, LLC
MARCS-CMS 554500 —
August 06, 2019
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Todd A. Troha
Recipient Title
General Manager
Healthy Healing Enterprises, LLC
7725 Washington Avenue S.
Minneapolis
,
MN
55439
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
250 Marquette Avenue
Suite 600
Minneapolis
,
MN
55401
United States
(612) 334-4100
Dear Mr. Troha:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated August 15, 2018. Based on our evaluation, it appears that 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/
Boun M. Xiong
Compliance Officer, West Division 1 – CB
Office of Human and Animal Food Operations
Content current as of:
08/07/2019
Regulated Product(s)
Drugs
Food & Beverages
CLOSEOUT LETTER
Holdgrafer Dairy Inc.
MARCS-CMS 518298 —
February 22, 2019
Delivery Method:
UPS
Recipient:
Recipient Name
Scott L. Holdgrafer
Recipient Title
President and Owner
Holdgrafer Dairy Inc.
Holdgrafer Dairy Inc.
20070 328th Avenue
Bellevue
,
IA
52031
United States
Issuing Office:
Center for Veterinary Medicine
8050 Marshall Drive
Suite 205
Lenexa
,
KS
66214-1524
United States
913-495-5100
Dear Mr. Holdgrafer:
The Food and Drug Administration has completed an evaluation of Holdgrafer Dairy, Inc. corrective actions in response to our Warning Letter (CMS Case #: 518298) on March 11, 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/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
03/08/2019
CLOSEOUT LETTER
Holy Land Brand Inc.
MARCS-CMS 552966 —
May 30, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Majdi M. Wadi
Recipient Title
CEO/Owner
Holy Land Brand Inc.
2709 Broadway Street NE
Minneapolis
,
MN
55413-1736
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Wadi:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 552966 dated June 29, 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,
/S/
Dianna C. Sonnenburg
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
06/05/2019
Regulated Product(s)
Food & Beverages