tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
PepsiCo, Inc.
MARCS-CMS 679972 —
September 10, 2024
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Ramon Laquarta
Recipient Title
CEO
PepsiCo, Inc.
The Quaker Oats Co.
700 Anderson Hill Road
Purchase
,
NY
10577
United States
Ramon.laguarta@pepsico.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Secondary Issuing Offices
United States
Dear Mr. Laquarta:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS#679972), dated June 12, 2024. Based on our evaluation, it appears that you have addressed the violation(s) by permanently closing your Danville, IL facility. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of corrections at all locations.
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/
LCDR Audrey DeLa Cruz
Acting, Director of Compliance
Office of Human and Animal Food
Division HAFE6
Content current as of:
09/17/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Perfection Bakeries Inc, dba Aunt Millie's Bakeries
MARCS-CMS 657559 —
March 19, 2024
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
John Popp
Recipient Title
Owner
Perfection Bakeries Inc, dba Aunt Millie's Bakeries
350 Pearl Street
Fort Wayne
,
IN
46802
United States
jpopp@auntmillies.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Secondary Issuing Offices
United States
Dear Mr. Popp:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued on September 7, 2023. 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.
If you have questions concerning this letter, please contact me at Lauren.Sexton@fda.hhs.gov.
Sincerely,
/S/
Lauren E. Sexton
Compliance Officer
Office of Human and Animal Food Operations
Division East 6
Detroit District Office
Content current as of:
03/25/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Pop Daddy Popcorn, LLC
MARCS-CMS 646807 —
February 07, 2024
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mark T. Sarafa
Recipient Title
Managing Member/President/Co-Owner
Pop Daddy Popcorn, LLC
5775 Brighton Pines Ct
Howell
,
MI
48843-6403
United States
Mark.sarafa@popdaddysnacks.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Secondary Issuing Offices
United States
Dear Mr. Sarafa:
The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY23-HAFE6-03 CMS 646807, issued on 03/28/2023. 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 continuing 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 Kelli L. Wilkinson
Director of Compliance
Office of Human and Food Operations
Division East 6
Content current as of:
02/12/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Premier Food Supplies LLC
MARCS-CMS 656160 —
July 31, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Jagdish Rughani
Recipient Title
Owner
Premier Food Supplies LLC
1783 Thunderbird
Troy
,
MI
48084-5465
United States
Issuing Office:
Division of Northern Border Imports
United States
Secondary Issuing Offices
United States
Dear Mr. Jagdish Rughani:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 656160 dated July 14, 2023. 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/
Sherea L. Dillon
Director of Compliance
Division of Northern Border Imports
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
08/13/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Professional Disposables International, Inc.
MARCS-CMS 617201 —
December 05, 2024
Reference #:
FEI 2411192
Product:
Drugs
Recipient:
Recipient Name
Mr. Zachary Julius
Recipient Title
CEO
Professional Disposables International, Inc.
4855 Pine Tree Drive
Miami Beach
,
FL
33140
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Secondary Issuing Offices
United States
Dear Mr. Julius:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 617201 dated January 07, 2022.
Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter pertaining to Professional Disposables International, Inc., FEI 2411192. 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/
Emmanuel Ramos
Compliance Officer
Division of Drug Quality III
Office of Manufacturing Quality
Content current as of:
12/12/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Quicksilver Scientific, Inc.
MARCS-CMS 612476 —
September 30, 2024
Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Christopher W. Shade, PhD
Quicksilver Scientific, Inc.
1960 Cherry Street
Louisville
,
CO
80027
United States
chris.shade@quicksilverscientific.com
Issuing Office:
Office of Human and Animal Food Operations Division West 4
United States
Secondary Issuing Offices
United States
Dear Dr. Shade:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS Case # 612476, dated October 13, 2021. 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/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
Content current as of:
10/03/2024
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Revival Products, Inc.
MARCS-CMS 606640 —
August 05, 2024
Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Suzanne S. Tabor
Recipient Title
President
Revival Products, Inc.
200 Peddycord Park Ct
Kernersville
,
NC
27284-9827
United States
Issuing Office:
Office of Human and Animal Food Operations – East Division 3
United States
Secondary Issuing Offices
United States
Dear Ms. Tabor:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS #606640 dated August 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,
/S/
LCDR N’Jere English, Ph.D.
Compliance Officer
Office of Human and Animal Foods, East Division 3
Office of Regulatory Affairs
U.S. Food and Drug Administration
Content current as of:
08/05/2024
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Rongcheng Jiayuan Food Co., Ltd
MARCS-CMS 682456 —
October 16, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. LiBo Yu
Recipient Title
General Manager
Rongcheng Jiayuan Food Co., Ltd
No. 186 Longyu Road
Rongcheng Shi
Weihai Shi
Shandong Sheng
,
264311
China
libo.yu@jy-group.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Secondary Issuing Offices
United States
Dear Mr. LiBo Yu:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 682456, issued May 31, 2024. 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/
Robyn R. Jones
Branch Chief
Conventional Foods Enforcement Branch #2
Office of Compliance and Enforcement
The Human Foods Program
Content current as of:
11/15/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
The Skin Atelier, Inc. d.b.a. Skinprint
MARCS-CMS 582512 —
October 29, 2024
Reference #:
FEI 3005976760
Product:
Drugs
Recipient:
Recipient Name
Mr. Robert P. Manzo
Recipient Title
President/CEO
The Skin Atelier, Inc. d.b.a. Skinprint
1997 Route 17 M, Suite 10
Goshen
,
NY
10924
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
Secondary Issuing Offices
United States
Dear Mr. Manzo:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 582512 dated October 1, 2019.
Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter pertaining to CGMP violations. 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/
Emily Wu
Compliance Officer
Division of Drug Quality II
Content current as of:
11/05/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Sohgave LLC
MARCS-CMS 646874 —
December 16, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Juan Trujillo
Recipient Title
Owner
Sohgave LLC
2293 Hawes Ave Apt 1106
Dallas
,
TX
75235
United States
Issuing Office:
Division of Southwest Imports
United States
Secondary Issuing Offices
United States
Dear Mr. Trujillo:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS case file #646874, issued on 01/19/2023. 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/
Alina Schmidt
Compliance Officer
Division of Southwest Imports
Content current as of:
12/31/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Suther Feeds, Inc.
MARCS-CMS 653966 —
March 08, 2024
Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Recipient:
Recipient Name
Dr. Michael P. Johll
Recipient Title
Majority Owner/VP/COO
Suther Feeds, Inc.
105 S. Kansas Avenue
Frankfort
,
KS
66427-1331
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
Secondary Issuing Offices
United States
Dear Dr. Johll,
The Food and Drug Administration has completed an evaluation of Suther Feeds, Inc. corrective actions in response to our Warning Letter (CMS case #: 653966 August 21, 2023). Based on our recent inspection conducted February 12-15, 2024, 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, Ph.D.
Program Division Director
Office of Human and Animal Food
West Division II
Content current as of:
03/12/2024
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Swity d.o.o.
MARCS-CMS 682450 —
July 31, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Enis Bajramovic
Recipient Title
Director
Swity d.o.o.
Sarajevska Ulica 122
Federacija Bosne i Hercegovine
76250
Gradacac
Bosnia & Herzegovina
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Secondary Issuing Offices
United States
Dear Mr. Bajramovic,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 682450 issued May 16, 2024. 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/
Maria Corpuz
Branch Chief
Food Adulteration and Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
06/03/2025
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S.
MARCS-CMS 659854 —
August 14, 2024
Product:
Drugs
Recipient:
Recipient Name
Mr. Hakan Tuna
Recipient Title
President/Chairman of the Board
Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S.
No. 32 Omerli Mahallesi, Uran Caddesi
34799
Cekmekoy
/
İstanbul
Turkey
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
Dear Mr. Tuna:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-29 dated August 3, 2023.
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/
Reba Gates
Compliance Officer
Division of Drug Quality II
Content current as of:
08/30/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
TeaTaze, LLC
MARCS-CMS 613942 —
June 14, 2024
Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
Nicholas P Gerstner
TeaTaze, LLC
1203 N Fieldcrest St
Wichita
,
KS
67212
United States
Issuing Office:
Office of Human and Animal Food- West Division II
United States
Secondary Issuing Offices
United States
Dear Mr. Gerstner:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 613942) on July 23, 2021. 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/
LaTonya M. Mitchell, Ph.D.
Program Division Director,
Office of Human and Animal Food-West Div. 2
Content current as of:
07/01/2024
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Terragene S.A.
MARCS-CMS 667432 —
April 05, 2024
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Esteban Lombardia
Recipient Title
CEO
Terragene S.A.
Ruta Nacional N9
Km 280, CP 2130, Parque Industrial Micropi
2130
Alvear
Santa Fe
Argentina
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. Esteban Lombardia:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS case # 667432, dated November 01, 2023. 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/
Binita Ashar, M.D., M.B.A., F.A.C.S.
Director
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health April 5, 2024
CC
:
US AGENT: Benny Arazy
US AGENT ADDRESS: medes@arazygroup.com
Content current as of:
06/28/2024
Regulated Product(s)
Medical Devices