tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
World Organic Corp.
MARCS-CMS 441366 —
December 17, 2018
Recipient:
Recipient Name
Paul J. Licata
Recipient Title
President
World Organic Corp.
World Organic Corp.
5242 Bolsa Avenue
Suite 3
Huntington Beach
,
CA
92649-1054
United States
Issuing Office:
Center for Devices and Radiological Health
19701 Fairchild
Irvine
,
CA
92612-2506
United States
Dear Mr. Licata:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #32-16, issued June 17, 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 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/
Compliance Branch Director
Office of Human and Animal Food
Division of Human and Animal Feed West 5
Content current as of:
10/10/2018
CLOSEOUT LETTER
WR Group, Inc.
MARCS-CMS 524181 —
October 31, 2018
Recipient:
Recipient Name
Carey Williams
Recipient Title
CEO/Owner
WR Group, Inc.
WR Group, Inc.
9160 Bahia Drive
Suite 200
Scottsdale
,
AZ
85260
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
Office of Human and Animal Food Operations - Division IV West
United States
Dear Mr. Williams:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter HAFW4(DEN)-17-19-WL, dated September 7, 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:
11/06/2018
CLOSEOUT LETTER
Zarbee's Naturals Inc.
March 13, 2018
Recipient:
Zarbee's Naturals Inc.
United States
Issuing Office:
United States
6th Ave & Kipling St, DFC Bldg 20
PO Box 25087
Denver, CO 80225-0087
March 13, 2018
VIA UPS Overnight
Mr. Bret Furio, CEO
Zarbee's Inc.
50 Old Field Point Rd
Greenwich, CT 06830
Ref : DEN-14-09-WL
Dear Mr. Furio:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-14-09-WL, dated June 27, 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 actions should violations be observed during a subsequent inspection of through other means.
Sincerely,
/S/
LaTonya M. Mitchell
Denver District Director
Program Division Director
Office of Human and Animal Food - Division IV West
Content current as of:
03/22/2018
CLOSEOUT LETTER
Zhejiang Hisoar Pharmaceutical Co. Ltd.
MARCS-CMS 486933 —
June 05, 2018
Recipient:
Zhejiang Hisoar Pharmaceutical Co. Ltd.
United States
Issuing Office:
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
June 5, 2018
Hongming Li
Executive VP, Pharmaceutical Division CEO
Zhejiang Hisoar Phannaceutical Co., Ltd.
No. 100 Waisha Branch Road
Jiaojiang Taizhou, Zhejiang 318000
China
Reference: FEI 3003735151
Dear Mr. Li:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-16-26 dated August 11, 2016. Based on our evaluation, it appears that you have 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/
Daniel W. Brisker
Compliance Officer
Division of Drug Quality II
Content current as of:
06/11/2018
CLOSEOUT LETTER
Zynex Medical, Inc.
MARCS-CMS 423378 —
December 18, 2018
Delivery Method:
UPS Overnight
Reference #:
DEN-14-08-WL
Product:
Medical Devices
Recipient:
Recipient Name
Thomas Sandgaard
Recipient Title
Founder, Chairman and CEO
Zynex Medical, Inc.
9555 Maroon Circle
Englewood
,
CO
80112
United States
Issuing Office:
Office of Medical Device & Radiological Health Operations Division 3/West
United States
Dear Mr. Sandgaard:
The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter DEN-14-08-WL, dated June 27, 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 subsequent inspections or through other means.
Sincerely,
/S/
Kelly Sheppard
Director, Compliance Branch
Office of Medical Device & Radiological Health Operations
Division 3/West
Content current as of:
12/31/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Zyno Medical, LLC
MARCS-CMS 507058 —
December 03, 2018
Recipient:
Recipient Name
Chaoyoung Lee, Ph.D.
Recipient Title
President & CEO
Zyno Medical, LLC
Zyno Medical, LLC
177 Pine Street
Natick
,
MA
01760-1029
United States
cylee@careeverywhere.com
Issuing Office:
Center for Devices and Radiological Health
One Montvale Avenue
4th floor
Stoneham
,
MA
02180
United States
Dear Dr. Lee:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated December 5, 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/
Gina Brackett
Director of Compliance
Office of Medical Device and Radiological Health Division 1
U.S. Food and Drug Administration
Content current as of:
12/04/2018
CLOSEOUT LETTER
1ViZN LLC
MARCS-CMS 522724 —
February 06, 2019
Delivery Method:
UPS Overnight
Recipient:
Recipient Name
M. Bruce Davis
Recipient Title
Founder and President
1ViZN LLC
1ViZN LLC
1180 N Mountains Springs Parkway
Springville
,
UT
84663
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Amended Warning Letter DEN-17-16-WL, dated August 23, 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:
03/21/2019
CLOSEOUT LETTER
ABC Compounding Company Inc
MARCS-CMS 576953 —
May 02, 2019
Product:
Drugs
Recipient:
Recipient Name
Jon Craytor
ABC Compounding Company Inc
2600 Dogwood Dr. NE
Conyers
,
GA
30013
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Mr. Craytor:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1398, issued on April 18, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and corrected the data deficiencies. 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. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection 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:
05/07/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Abington Memorial Hospital, IRC
MARCS-CMS 576854 —
August 28, 2019
Reference #:
CBER-19-02
Product:
Biologics
Recipient:
Recipient Name
G. Chris Christensen III
Recipient Title
Chairman
Abington Memorial Hospital, IRC
1200 Old York Road
Abington
,
PA
19001
United States
Issuing Office:
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
WO 71 RM 5128
Silver Spring
,
MD
20993
United States
Dear Dr. Christensen:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CBER-19-02 dated June 24, 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 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/
Mary A. Malarkey, Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
CC: Lisa K. Buchanan, Director
Division of Compliance Oversight
Office of Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
Content current as of:
08/30/2019
Regulated Product(s)
Biologics
CLOSEOUT LETTER
Adaptive Energy LLC
MARCS-CMS 553626 —
June 04, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Nodari Rizun
Adaptive Energy LLC
109 E 17th St. Ste 4
Cheyenne
,
WY
82001
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Rizun:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 553626, issued September 6, 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 finn 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)
Dietary Supplements
CLOSEOUT LETTER
Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc.
April 24, 2019
Delivery Method:
TRANSMITTED BY FACSIMILE
Product:
Drugs
Recipient:
Recipient Name
Warren P. Lesser, DBA, MBA
Recipient Title
President/CEO
Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc.
10801 Electron Drive, Suite 100
Louisville
,
KY
40299
United States
Issuing Office:
The Office of Prescription Drug Promotion (OPDP)
United States
RE: NDA 022196
Zolpimist (zolpidem tartrate) Oral Spray (C-IV)
RE: NDA 022196
Zolpimist (zolpidem tartrate) Oral Spray (C-IV)
MA 9
Dear Dr. Lesser:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated November 14, 2017. 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 9 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official.
Sincerely,
{See appended electronic signature page}
Christine Bradshaw, PharmD, RAC
Regulatory Review Officer
Division of Advertising & Promotion Review 1
Office of Prescription Drug Promotion
cc: Suzane Kelderman – CMQ/OE
Director of Regulatory Affairs and Quality Assurance
Aytu BioScience, Inc.
373 Inverness Parkway, Suite 206
Englewood, CO 80112
--------------------------------------------------------------------------------------------
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/
------------------------------------------------------------
CHRISTINE J BRADSHAW
04/24/2019 02:21:02 PM
Content current as of:
04/24/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
AMJ Distribution Company
MARCS-CMS 497988 —
June 19, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Anne Marie A. Johnson
Recipient Title
Owner
AMJ Distribution Company
6317 Welcome Avenue North
Suite 13
Brooklyn Park
,
MN
55429-2017
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 Ms. Johnson:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter MIN 16-12 dated June 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 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:
06/21/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Anigan, Inc.
MARCS-CMS 557163 —
September 26, 2019
Product:
Medical Devices
Recipient:
Recipient Name
Ai Chen (Sarah) Teo
Recipient Title
President and General Manager
Anigan, Inc.
6550 Bennington Way
San Ramon
,
CA
94582-3902
United States
Issuing Office:
Office of Medical Device and Radiological Health Operations (Division 3W)
19701 Fairchild
Irvine
,
CA
92612
United States
Dear Ms. Teo:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [WL CMS 557163 dated July 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/
Director of Compliance Branch
Office of Medical Device and Radiological Health
Division 3/West
Content current as of:
09/30/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Aphena Pharma Solutions-Tennessee, LLC
MARCS-CMS 542310 —
January 31, 2019
Product:
Drugs
Recipient:
Aphena Pharma Solutions-Tennessee, LLC
United States
Issuing Office:
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
January 31, 2018
Chris Campbell
Aphena Pharma Solutions - Tennessee, LLC
1920 Fisk Road
Cookeville, TN 38506
Mr. Campbell,
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1190 and 1161. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and corrected the data deficiencies. 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. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Maria Rossana (Rosemary) R. Cook
Director
Office of Program and Regulatory Operations
Office of Compliance
Center for Drug Evaluation and Research
Telephone: 301-348-3968
maria.cook@fda.hhs.gov
Content current as of:
02/02/2018
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Apnea Sciences Corporation
MARCS-CMS 392712 —
April 29, 2019
Delivery Method:
United Parcel Service
Product:
Medical Devices
Recipient:
Recipient Name
James Fallon
Recipient Title
CEO
Apnea Sciences Corporation
27121 Aliso Creek Rd
Ste 140
Aliso Viejo
,
CA
92656-5308
United States
Issuing Office:
Center for Devices and Radiological Health
19701 Fairchild Road
Los Angeles
,
CA
92612
United States
Dear Mr. Fallon:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #37-13), dated 05/09/2013. 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/
Jeffrey Wooley
(Acting) Compliance Branch Director
FDA/Office of Regulatory Affairs
Office of Medical Device and Radiological Health Operations
Division 3/West Compliance Branch
Content current as of:
05/09/2019
Regulated Product(s)
Medical Devices