tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Homeodynamics, LLC
MARCS-CMS 539270 —
September 18, 2019
Product:
Drugs
Recipient:
Recipient Name
Michael J. Leger
Recipient Title
Owner and President
Homeodynamics, LLC
7137 Lindfield Road
Madison
,
WI
53719-2132
United States
Issuing Office:
Division of Human and Animal Food Operations West I (HAFW1)
250 Marquette Avenue
Suite 600
Minneapolis
,
MN
55401
United States
612) 334-4100
Dear Mr. Leger:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 539270 dated February 20, 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/
Boun M. Xiong
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
09/23/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Hood River Juice Company, Inc.
MARCS-CMS 544482 —
April 01, 2019
Delivery Method:
Overnight Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
David B. Ryan
Recipient Title
President
Hood River Juice Company, Inc.
550 Riverside Drive
Hood River
,
OR
97031
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Ryan:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 544482 dated April 25, 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/
Miriam R. Burbach
District Director
Program Division Director
cc: Oregon Department of Agriculture
Food Safety Division
635 Capitol Street NE
Salem, Oregon 97301
Content current as of:
04/11/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Iberia Foods Company of New York, Inc
MARCS-CMS 435841 —
March 13, 2019
Delivery Method:
United Parcel Service
Recipient:
Recipient Name
Eric S. Miller
Recipient Title
CEO
Iberia Foods Company of New York, Inc
Iberia Foods Company of New York, Inc
1900 Linden Boulevard
Brooklyn
,
NY
11207-6806
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
158-15 Liberty Avenue
Jamaica
,
NY
11433
United States
Dear Mr. Miller:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2014-53, issued on July 31, 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 Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
03/19/2019
CLOSEOUT LETTER
IDT Australia Ltd.
MARCS-CMS 547605 —
August 27, 2019
Reference #:
FEI 3000219354
Product:
Drugs
Recipient:
Recipient Name
Dr. David Sparling
Recipient Title
CEO
IDT Australia Ltd.
45 Wadhurst Drive
Boronia
VIC
3155
Australia
Issuing Office:
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Dr. Sparling:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-18-55 dated May 23, 2018. Based on our evaluation, it appears that you have addressed the violations and 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 violations and deviations be observed during a subsequent inspection or through other means.
Sincerely.
/S/
Bryce A. Hammer
Compliance Officer
Division of Drug Quality II
Content current as of:
09/09/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Ignatius P. Godoy, M.D.
MARCS-CMS 561662 —
March 06, 2019
Recipient:
Recipient Name
Ignatius P. Godoy, M.D.
Ignatius P. Godoy, M.D.
Ignatius P. Godoy, M.D.
16660 Paramount Boulevard
Suite 206
Paramount
,
CA
90723-5458
United States
Issuing Office:
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Dr. Godoy:
The Food and Drug Administration completed an evaluation of your corrective actions in response to our Warning Letter CBER-19-01 dated October 1, 2018. Based on our evaluation, it appears that you 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 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 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/
Mary A. Malarkey, Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Content current as of:
03/12/2019
CLOSEOUT LETTER
INCELL Corporation LLC
MARCS-CMS 491621 —
May 24, 2019
Delivery Method:
UPS EXPRESS
Reference #:
2017-DAL-WL-02
Product:
Drugs
Recipient:
Recipient Name
Mary P. Moyer
Recipient Title
President & Chief Science Officer
INCELL Corporation LLC
12734 Cimarron Path
San Antonio
,
TX
78249-3424
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Dr. Moyer:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s response to our warning letter (ref: WL # 2017-DAL-WL-02). We acknowledge that, in response to our warning letter, you have chosen to de-register your facility and discontinue operations as a 503B outsourcing facility. We note that de-registration was completed on December 30, 2016.
Should your firm decide to resume production of drug products, FDA strongly recommends that you undertake a comprehensive assessment of your operations, and that you notify FDA prior to resuming drug production. 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.
If you have questions regarding the contents of this letter, please contact John W. Diehl at
(214) 253-5288
.
Sincerely,
/S/
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
05/31/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Inova Genomics Laboratory
MARCS-CMS 577422 —
May 24, 2019
Product:
Medical Devices
Recipient:
Recipient Name
Ramaswamy Iyer
Recipient Title
Director
Inova Genomics Laboratory
3300 Gallows Road
Claude Moore Building, 2nd Floor
Falls Church
,
VA
22042
United States
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Dr. Iyer:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 577422, dated April 4, 2019). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA 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.
Sincerely yours,
/S/
Timothy T. Stenzel, M.D., Ph.D.
Director
Office of In Vitro Diagnostics and
Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
05/31/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Up Inya Gear
MARCS-CMS 553138 —
June 04, 2019
Product:
Drugs
Recipient:
Recipient Name
William Houck
Up Inya Gear
22 Centennial St.
Fairfield
,
PA
17320
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Houck:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 553138 issued June 7, 2018. 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:
06/05/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
IQ Formulations, LLC / DBA Metabolic Nutrition Inc.
MARCS-CMS 560790 —
June 17, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Jay Cohen
Recipient Title
President
IQ Formulations, LLC / DBA Metabolic Nutrition Inc.
10151 NW 67th St
Tamarac
,
FL
33321-6400
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Cohen:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS # 560790, 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
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Iron Brothers
MARCS-CMS 560784 —
June 17, 2019
Recipient:
Recipient Name
Marc Burton
Recipient Title
Partner
Iron Brothers
848 N. Rainbow Blvd. #4292
Las Vegas
,
NV
89107
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Burton:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS #560784, 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:
03/18/2020
CLOSEOUT LETTER
I.T.S. GmbH
MARCS-CMS 422665 —
July 01, 2019
Product:
Medical Devices
Recipient:
Recipient Name
Wolfgang Auf
Recipient Title
CEO
I.T.S. GmbH
Autal 28
Lasnitzhohe
8301
Steiermark
Austria
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Wolfgang Auf:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 422665, dated June 30, 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/
CAPT Raquel Peat, PhD, MPH, USPHS
Director
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
cc:
US Agent
Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200TH St.
Prior Lake, MN 5537
Content current as of:
07/10/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Jack B Goods Outlet Store
MARCS-CMS 566674 —
June 04, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Greg Lawrence
Jack B Goods Outlet Store
1024 Highland Cove Place
Ridgeland
,
MS
39157
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Lawrence:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 566674, issued November 7, 2018. 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
Jessie Commodity Co., Ltd.
MARCS-CMS 576935 —
May 20, 2019
Reference #:
#1271
Product:
Drugs
Recipient:
Recipient Name
David Wei
Jessie Commodity Co., Ltd.
Yuyao Jessie Commodity Co. Ltd.
No. 67 Zhenxing West Road
Yuyao
Zhejiang Sheng
,
315400
China
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Mr. David Wei:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1271, issued on April 18, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and delisted the product. Future FDA 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 to continue to monitor your state of compliance.
Your firm is expected to maintain the current contact information with FDA. Labeler code contact information, including physical address, email and other contact information, must be updated within 30 calendar days after any change to that information. 21 CFR § 207.33(c)(2). FDA uses this information for official communication regarding registration and listing matters. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection, submission review or through other means.
Sincerely,
/S/
Maria Rossana R. Cook
Director
Office of Program and Regulatory Operations
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
05/29/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
John Gray’s Mars Venus LLC
MARCS-CMS 564498 —
June 04, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
John Gray
John Gray’s Mars Venus LLC
20 Sunnyside Ave
Ste A130
Mill Valley
,
CA
94941
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Gray:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #564498, 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:
06/10/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Judge Farms Inc
MARCS-CMS 569128 —
September 10, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Bradley E. Barga
Recipient Title
President
Judge Farms Inc
5636 Demming Road
Ansonia
,
OH
45303
United States
Issuing Office:
Division of Human and Animal Food Operations East V (HAFE5)
6751 Steger Drive
Cincinnati
,
OH
45237
United States
(513) 679-2700
Dear Mr. Barga:
The Food and Drug Administration (FDA) completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 569128. 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/
Zada L. Giles
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East
Content current as of:
09/12/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Jugos La Torre
MARCS-CMS 537085 —
August 12, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
17-HAFE4-WL-10
Product:
Food & Beverages
Recipient:
Recipient Name
Angel J. Sanchez
Recipient Title
Owner
Jugos La Torre
Road 4131, Km. 2.0, Bo. La Torre
Lares
,
PR
00669-0540
United States
Issuing Office:
Office of Human and Animal Food Operations Division IV East
United States
(787) 729-8500
Dear Mr. Sanchez:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 17-HAFE4-WL-10 dated September 12, 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
OHAFO, Division IV East
Content current as of:
02/27/2020
Regulated Product(s)
Food & Beverages