tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Vita Pure Inc
MARCS-CMS 524473 —
January 14, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Achyut Sahasra
Recipient Title
President and Owner
Vita Pure Inc
410 West 1st Avenue
Roselle
,
NJ
07203
United States
Issuing Office:
Baltimore District Office
United States
Dear Mr. Sahasra:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued on November 8, 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 Ciaccia
Compliance Officer
Human and Animal Food East, Division II
Content current as of:
03/16/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
VitaCig Canada
MARCS-CMS 597072 —
October 22, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
RW1901215
Recipient:
Recipient Name
Ki-Il Kim
VitaCig Canada
United States
vitacigcad@gmail.com
support@vitacig-canada.com
nibocnc@gmail.com
Issuing Office:
Center for Tobacco Products
United States
Dear Ki-Il Kim:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your responses, dated November 27, 2019 and December 9, 2019, in response to our Warning Letter dated November 26, 2019. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://www.vitacig-canada.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
10/26/2020
CLOSEOUT LETTER
Vitalab Pharmacy, Inc. dba Vasco Rx Specialty Pharmacy
MARCS-CMS 570563 —
February 06, 2020
Product:
Drugs
Recipient:
Recipient Name
Vladimir Lenchitsky
Recipient Title
Founder and Chairman of the Board
Vitalab Pharmacy, Inc. dba Vasco Rx Specialty Pharmacy
4045 E. Bell Rd.
Suite 163
Phoenix
,
AZ
85032
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
949-608-2900
Dear Mr. Lenchitsky :
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# 570563) dated January 10, 2019. 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 ensure 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:
02/10/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Welter Farms Inc
MARCS-CMS 562966 —
February 04, 2020
Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Recipient:
Recipient Name
Nicholas S. Welter, Randy Welter, Dan Welter
Recipient Title
Owners
Welter Farms Inc
16836 Hannan Road
Holy Cross
,
IA
52053-9762
United States
Issuing Office:
Office of Human and Animal Food Division II West
United States
913-495-5100
Dear Messrs. Welter:
The Food and Drug Administration has completed an evaluation of Welter Farms Inc.
corrective actions in response to our Warning Letter (CMS case #: 562966) on November 28, 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:
02/05/2020
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Whitehall/Div of Acorn Engineering Co
MARCS-CMS 525297 —
July 02, 2020
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Donald L. Morris
Recipient Title
CEO and Owner
Whitehall/Div of Acorn Engineering Co
15125 Proctor Avenue
City of Industry
,
CA
91746-3327
United States
bmorris@acorneng.com
Issuing Office:
Office of Medical Devices and Radiological Health Operations
United States
Dear Mr. Donald Morris,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #525297-17), dated 7/12/2017. 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/
Jessica Mu
Compliance Branch Director
Office of Medical Devices and Radiological Health Operations
Division 3/West
Content current as of:
07/02/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Wise Spice Catering Company
MARCS-CMS 533921 —
November 23, 2020
Delivery Method:
VIA Electronic Mail
Reference #:
18-HAFE4-WL-01
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Fernando De La Cruz
Recipient Title
Owner
Wise Spice Catering Company
196 West 25th Street
Hialeah
,
FL
33010
United States
fernandodelacruz454@yahoo.com
Issuing Office:
Office of Human and Animal Food Operations Division IV East
United States
(787) 729-8500
Dear Mr. De La Cruz:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 18-HAFE4-WL-01 dated November 1, 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:
12/01/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
The Wonderful Company
MARCS-CMS 499010 —
May 01, 2020
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Stewart Resnick
Recipient Title
President and Chairman
The Wonderful Company
Paramount Farms
11444 West Olympic Blvd
Los Angeles
,
CA
90064
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Mr. Resnick:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, 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 Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
05/07/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Yost Foods, Inc
MARCS-CMS 581473 —
March 24, 2020
Delivery Method:
Via Email
Recipient:
Recipient Name
William L. Yost
Recipient Title
President
Yost Foods, Inc
2795 Westway Drive
Brunswick
,
OH
44212
United States
Issuing Office:
Division of Human and Animal Food Operations East V (HAFE5)
United States
(513) 679-2700
Dear Mr. Yost:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter #581473 that we issued on 9/10/2019. 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.
/S/
Stephen J. Rabe
Compliance Officer
Content current as of:
03/31/2020
CLOSEOUT LETTER
21st Century Scientific Inc
MARCS-CMS 566834 —
November 04, 2021
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Ronald D. Davidson
Recipient Title
Chief Operating Officer
21st Century Scientific Inc
4931 N. Manufacturing Way
Coeur d Alene
,
ID
83815
United States
rdd@wheelchairs.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Davidson:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated May 13, 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/
Jessica Mu,
Director, Compliance Branch
Office of Medical Devices and
Radiological Health, Division III
Content current as of:
11/04/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Abaxis Inc
MARCS-CMS 558421 —
December 17, 2021
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Simon Sunderland
Recipient Title
Board of Directors Officer for Quality
Abaxis Inc
3240 Whipple Rd.
Union City
,
CA
94587-1217
United States
simon.sunderland@zoetis.com
Issuing Office:
Office of Medical Device and Radiological Health Operations
United States
Dear Mr. Sunderland,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to a Warning Letter dated 4/12/2019. 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/
Jessica Mu
Compliance Branch Director
Office of Medical Devices and Radiological Health Operations
Division 3/West
cc:
Roni Thebo, Director – Global Diagnostics Regulatory Affairs and Pharmacovigilance,
roni.m.thebo@zoetis.com
Content current as of:
12/17/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Aceva, LLC
MARCS-CMS 614539 —
November 03, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Joseph Esposito
Recipient Title
CEO
Aceva, LLC
624 West Glen Ave.
Peoria
,
IL
61614
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Joseph Esposito:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Re: 614539, issued September 7, 2021. Based on our evaluation, it appears you have addressed the violation(s) contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
cc:
HFS-605
CMS # 614539/ WA# 417986
FEI# 3014511804
Content current as of:
11/10/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Actavis Laboratories FL, Inc.
MARCS-CMS 567857 —
September 01, 2021
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Kristopher J. Preisinger
Recipient Title
Site General Manager
Actavis Laboratories FL, Inc.
4955 Orange Dr.
Davie
,
FL
33314
United States
Issuing Office:
Dallas District Office
United States
Mr. Preisinger:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter # 567857 dated February 1, 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.
If you have questions regarding the contents of this letter, you may contact Jamillah Selby, Compliance Officer via phone at
214-253-5218
or email at
jamillah.selby@fda.hhs.gov
Sincerely,
/S/
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
09/07/2021
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Allimax Us
MARCS-CMS 609328 —
March 18, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Bobbi Walton
Allimax Us
500 West Superior Street
Unit 2205/#2205
Chicago
,
IL
60654
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Ms. Walton:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 609328, issued January 12, 2021. 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
Food and Drug Administration
Content current as of:
03/22/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
American Nutriceuticals LLC
MARCS-CMS 608998 —
January 28, 2021
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Stephen Kravitz
American Nutriceuticals LLC
9700 NE 126th Avenue
Vancouver
,
WA
98682
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Dear Mr. Kravitz:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 608998, issued October 9, 2020. 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
Food and Drug Administration
CC:
Ms. Bethany R. Kennedy, Esq.
Mr. Jonathan W. Emord, Esq.
Emord & Associates
2730 South Val Vista Drive
Gilbert, AZ 85295
Content current as of:
02/01/2021
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
American Preclinical Services
MARCS-CMS 562382 —
August 09, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Michael Conforti, DVM, MS, MBA
Recipient Title
Vice President of Preclinical Operations
American Preclinical Services
8945 Evergreen Blvd NW
Minneapolis
,
MN
55433-6043
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Dr. Conforti:
The purpose of this letter is to inform you that the Food and Drug Administration (FDA) inspection conducted at your clinical site from May 10, 2021 to May 21, 2021 revealed no significant concerns. The FDA has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (WL) dated February 12, 2019. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this WL and has implemented the corrective actions, as promised in your response letters, dated October 25, 2018, November 9, 2018, November 30, 2018, December 11, 2018, March 1, 2019, April 8, 2019 and June 14, 2019.
This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely yours,
/S/
Sheena A. Green, MS
Assistant Director
DCEA1: Division of Clinical Science and
Quality
OCEA: Office of Clinical Evidence and Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
08/13/2021
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Angiplast Private Limited
MARCS-CMS 607616 —
April 30, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Asitt B. Shah
Recipient Title
Director and Owner
Angiplast Private Limited
4803 Phase IV
G.I.D.C., Vatva
Ahmedabad
382445
Gujarat
India
asitt@angiplast.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Asitt B. Shah:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 607616, May 14, 2020). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely yours,
/S/
Sharon M. Andrews
Director
DHT3B: Division of Reproductive,
Gynecology and Urology Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Earl G. Christensen
SteriGear, Inc.
362 S, University Avenue
Provo, UT US 84601
Phone:
(801) 607-3211
Email:
echristensen@sterigear.com
Content current as of:
05/11/2021
Regulated Product(s)
Medical Devices