tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Kwokcheng Enterprise, Inc. dba Fullei Fresh
MARCS-CMS 579900 —
August 01, 2023
Delivery Method:
VIA Electronic Mail
Reference #:
23-HAFE4-WLCOL-05
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Kwok-Cheng Wong
Recipient Title
President
Kwokcheng Enterprise, Inc. dba Fullei Fresh
400 NE 67th Street
Miami
,
FL
33138-3880
United States
manny@fulleifresh.com
fullei@fulleifresh.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV
United States
Dear Mr. Wong:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 20-HAFE4-WL-01 dated October 22, 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/
Pearl E. Lopina -S
Pearl Lopina
Director of Compliance Branch OHAFO, Division IV East
Content current as of:
08/21/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
La Ilusion Fresh Guava Inc.
MARCS-CMS 631141 —
March 08, 2023
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Javier Serna Flores
Recipient Title
Owner
La Ilusion Fresh Guava Inc.
10313 Long Ave
Oak Lawn
,
IL
60453-4642
United States
Issuing Office:
Division of Northern Border Imports
United States
Dear Mr. Javier Serna Flores:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 631141 dated May 12, 2022. 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:
03/14/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Laboratoires Clarins
MARCS-CMS 568157 —
January 23, 2023
Reference #:
3002759467
Product:
Drugs
Recipient:
Recipient Name
Mr. Jonathan Zrihen
Recipient Title
CEO
Laboratoires Clarins
Clarins Group
12, avenue de la Porte-des-Ternes
75017
Paris
France
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Zrihen:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-20 dated April 23, 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 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/
Philip Kreiter
Compliance Officer
Division of Drug Quality II
CC:
Ms. Cécile Mansuy
Operations Director
Laboratoires Clarins
5 rue Ampére
95300 Pontoise
France
Content current as of:
01/27/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Langlinais’ Baking Company
MARCS-CMS 625493 —
May 08, 2023
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Robbie Langlinais
Recipient Title
President/CEO
Langlinais’ Baking Company
814 West Congress St.
Lafayette
,
LA
70501
United States
robbie@langlinaisbakery.com
Issuing Office:
Office of Human and Animal Foods Operations-East
United States
Dear Mr. Langlinais:
The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter 625493, dated March14, 2022. 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/
Christopher N. Dedeaux
Compliance Officer
Office of Human and Animal Foods Operations
Division 5 East
Content current as of:
05/15/2023
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Leaf of Life LLC
MARCS-CMS 619191 —
January 18, 2023
Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
Michael A. Bolan
Recipient Title
Owner
Leaf of Life LLC
12355 Country Glen Lane
Creve Coeur
,
MO
63141
United States
Issuing Office:
Office of Human and Animal Food- West Division II
United States
Dear Mr. Bolan,
The Food and Drug Administration has completed an evaluation of Leaf of Life LLC corrective actions in response to our Warning Letter (CMS case # 619191 dated August 4, 2022) during our investigation conducted on October 27, 2022. 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 Foods-West Division 2
Content current as of:
01/23/2023
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Leimax, Corp.
MARCS-CMS 633364 —
December 22, 2023
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Noe Ramirez
Recipient Title
Owner & President
Leimax, Corp.
179 Saw Mill River Rd #B
Yonkers
,
NY
10701
United States
Issuing Office:
Foreign Supplier Verification Program (FSVP)
United States
Secondary Issuing Offices
United States
Dear Mr. Noe Ramirez:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 633364 dated October 7, 2022. Based on our evaluation, it appears that you have addressed the violation 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/
Anna Alexander
Director, Compliance Branch
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration
Content current as of:
01/03/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Livestock Nutrition Center, LLC
MARCS-CMS 643701 —
July 13, 2023
Delivery Method:
UPS Overnight
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mr. Ben Baer
Recipient Title
President
Livestock Nutrition Center, LLC
11225 College Blvd #330
Overland Park
,
KS
66210
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Dear Mr. Baer:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 643701 dated December 15, 2022) issued following an inspection of your animal food manufacturing facility (non-licensed medicated and non-medicated feed mill), located at 2900 Johnson Rd., Gonzales, TX 78629. 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/
Jessica E. Havranek
Director, Compliance Branch
Human & Animal Food Operations,
West Division 3
cc: Mr. Maurice G. Janda, Location Fulfillment Manager
Livestock Nutrition Center, LLC
2900 Johnson Rd.
Gonzales, TX 78629
cc: Mary Sasser, Program Director
Office of the Texas State Chemist
ATTN: Mary Sasser, Program Director
P.O. Box 3160
College Station, TX 77841-3160
Content current as of:
12/05/2023
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Luminex Corporation
MARCS-CMS 606267 —
June 14, 2023
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Carlo Rosa
Recipient Title
CEO
Luminex Corporation
DIASORIN S.P.A.
VIA CRESCENTINO, Snc
13040
Saluggia
VC
Italy
Carlo.Rosa@diasorin.it
Issuing Office:
Division of Medical Device and Radiological Health Operations West
United States
Dear Mr. Rosa:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #606267) dated June 26, 2020, that was issued to Luminex Corporation located at 12112 Technology Blvd., Austin, TX and 4088 Commercial Ave., Northbrook, IL, after it was acquired by DiaSorin S.P.A. on 7/14/2021. 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 Device and Radiological Health Operations
Division 3
Cc: Angelo Rago, President, arago@luminexcorp.com
Brian Levandowski, VP Manufacturing MDX, blevandowski@luminexcorp.com
Content current as of:
06/15/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Lydia Co Ltd.
MARCS-CMS 659646 —
August 18, 2023
Product:
Drugs
Recipient:
Recipient Name
Ho Dong Yang
Lydia Co Ltd.
102, Dongguk-ro
ILsandong-gu
Goyang-si
10325
South Korea
onbix@naver.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Ho Dong Yang:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2575. Based on our evaluation, it appears that you have addressed the violations contained in the warning letter and corrected the data discrepancies between labeling and electronic listing files, thus this warning letter is closed. 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. If this product is reintroduced in U.S. commercial distribution, FDA expects that all previous errors are corrected. 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/
Tina Smith
Acting Director, Office of Unapproved Drugs & Labeling Compliance
Center for Drug Evaluation and Research
Office of Compliance
U.S. Food and Drug Administration
Content current as of:
08/23/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Malladi Drugs & Pharmaceuticals Ltd.
MARCS-CMS 541915 —
January 31, 2023
Reference #:
3005115135
Product:
Drugs
Recipient:
Recipient Name
Mr. V.N. Gopalkrishnan
Recipient Title
Co-Founder & Chairman
Malladi Drugs & Pharmaceuticals Ltd.
SKCL Tech Square, 7th Floor, Plot No.: South Phase 14
Thiru Vi Ka Industrial Estate
Guindy, Chennai
600032
Tamil Nadu
India
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Gopalkrishnan:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-18-40 dated March 09, 2018.
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/
Frank Wackes
Compliance Officer
Division of Drug Quality II
Content current as of:
02/03/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Med Shop Total Care, Inc.
MARCS-CMS 581309 —
October 11, 2023
Delivery Method:
VIA Electronic Mail
Product:
Animal & Veterinary
Recipient:
Recipient Name
Jennifer D. Yoakum
Recipient Title
Co-Owner and Pharmacist-In-Charge
Med Shop Total Care, Inc.
479 E. Loop 281
Longview
,
TX
75605-7939
United States
jyoakum@medshoptotalcare.com
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
Dear Ms. Yoakum:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letters (Case #581309) dated July 30, 2019, and (Case #628182) dated March 18, 2022. Based on our evaluation, it appears that you have adequately addressed the violations contained in these warning letters.
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/
Ronda Loyd-Jones
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
10/24/2023
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
Med Shop Total Care Inc.
MARCS-CMS 628182 —
October 11, 2023
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Jennifer D. Yoakum
Recipient Title
Co-Owner and Pharmacist-In-Charge
Med Shop Total Care Inc.
479 E. Loop 281
Longview
,
TX
75605-7939
United States
jyoakum@medshoptotalcare.com
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
Dear Ms. Yoakum:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letters (Case #581309) dated July 30, 2019, and (Case #628182) dated March 18, 2022. Based on our evaluation, it appears that you have adequately addressed the violations contained in these warning letters.
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/
Ronda Loyd-Jones
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
Content current as of:
10/24/2023
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Medtronic MiniMed, Inc.
MARCS-CMS 617539 —
April 25, 2023
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Geoff Martha
Recipient Title
President & CEO
Medtronic MiniMed, Inc.
710 Medtronic Parkway, NE
USA-MN OHQ Corporate
Minneapolis
,
MN
55432
United States
Geoff.martha@medtronic.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Mr. Martha:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated December 9, 2021. 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:
04/28/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Mentor Worldwide LLC
MARCS-CMS 573520 —
May 03, 2023
Product:
Medical Devices
Recipient:
Recipient Name
Alenka Brzulja
Recipient Title
Worldwide President
Mentor Worldwide LLC
31 Technology Drive
Irvine
,
CA
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Dear Alenka Brzulja:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS Case# 573520, dated March 18, 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/
Binita S Ashar, MD, MBA, FACS
Director OHT4
Office of Surgery and Infection Control Devices
Office of Product Quality and Evaluation
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Content current as of:
05/15/2023
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Midwestern Pet Foods, Inc.
MARCS-CMS 613845 —
August 30, 2023
Delivery Method:
VIA Electronic Mail
Product:
Animal & Veterinary
Recipient:
Recipient Name
Jeffery J. Nunn
Recipient Title
President, CEO, Co-Owner
Midwestern Pet Foods, Inc.
9634 Hedden Rd.
Evansville
,
IN
47725
United States
rnunn@midwesternpetfoods.com
Issuing Office:
Center for Veterinary Medicine
United States
Dear Mr. Nunn:
The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY21-HAFE6-04, issued on 08/09/2021. 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:
09/11/2023
Regulated Product(s)
Animal & Veterinary