tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Legacy Pharmaceutical Packaging LLC
MARCS-CMS 633735 —
May 10, 2024
Reference #:
FEI 3004453700
Product:
Drugs
Recipient:
Recipient Name
Mr. Bradley M. Rayner
Recipient Title
President
Legacy Pharmaceutical Packaging LLC
13333 Lakefront Dr.
Earth City
,
MO
63045
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
Secondary Issuing Offices
United States
Dear Mr. Rayner:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #633735 dated October 3, 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 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/
Frank Wackes
Compliance Officer
Division of Drug Quality II
Content current as of:
05/30/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Lipari Foods Operating Company, LLC
MARCS-CMS 669083 —
September 27, 2024
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Thom Lipari
Recipient Title
President
Lipari Foods Operating Company, LLC
26661 Bunert Road
Warren
,
MI
48089-3650
United States
Thom_Lipari@liparifoods.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Secondary Issuing Offices
United States
Dear Mr. Lipari:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued on April 9, 2024. 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:
10/02/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Living Foods LLC
MARCS-CMS 622648 —
September 27, 2024
Delivery Method:
UPS Next Day
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Bruce D. Curtis
Recipient Title
Co-Owner
Living Foods LLC
1456 Marilee Dr.
Lawrence
,
KS
66049-5815
United States
Issuing Office:
Office of Human and Animal Food- West Division II
United States
Secondary Issuing Offices
United States
Dear Mr. Curtis:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS #622648, dated July 5, 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/
LaTonya M. Mitchell, Ph.D.
Program Division Director
Human and Animal Foods – West Division 2
Content current as of:
10/03/2024
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Lone Star Botanicals Inc.
MARCS-CMS 659735 —
June 25, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Tommy W. Kerzee
Recipient Title
Owner
Lone Star Botanicals Inc.
2001 Broussard St.
Tyler
,
TX
75701-8406
United States
Issuing Office:
Division of Human and Animal Food Operations East III
United States
Secondary Issuing Offices
United States
Dear Mr. Kerzee,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated November 6, 2023, issued following inspection of your facility located at 2001 Broussard St., Tyler, TX 75701. 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. If you choose to reestablish or sell your operations, 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/
Chad J. Whitwell
Acting Director, Compliance Branch
Office of Human and Animal Food, WD3
Content current as of:
07/01/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Marcus Research Laboratory, Inc.
MARCS-CMS 615153 —
October 02, 2024
Reference #:
FEI 1950348
Product:
Drugs
Recipient:
Recipient Name
Mr. Richard A. Gilbert
Recipient Title
President
Marcus Research Laboratory, Inc.
1820 Delmar Blvd.
St. Louis
,
MO
63103
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
Secondary Issuing Offices
United States
Dear Mr. Gilbert:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #615153 dated September 30, 2021.
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/
Christopher Keating
Compliance Officer
Division of Drug Quality II
Content current as of:
10/04/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
McKesson Corporation Headquarters
MARCS-CMS 565854 —
May 09, 2024
Delivery Method:
Via Electronic Mail Return Confirmation Requested
Product:
Drugs
Recipient:
Recipient Name
Brian Tyler
Recipient Title
CEO
McKesson Corporation Headquarters
6555 State Hwy 161
Irving
,
TX
75039
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Secondary Issuing Offices
United States
Dear Mr. Tyler:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #565854 dated February 7, 2019]. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
If you have questions regarding the contents of this letter, you may contact Rebecca Asente, Compliance Officer via (504) 846-6104 or via Rebecca.Asente@fda.hhs.gov.
Sincerely,
/S/
Ronda R.
Ronda Loyd-Jones
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II
Content current as of:
05/15/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Media Networks Sydney Pty Limited
MARCS-CMS 687044 —
September 18, 2024
Product:
Drugs
Recipient:
Recipient Name
Gilad Wielunski
Media Networks Sydney Pty Limited
36 Mid Dural Rd
Galston
NSW
2159
Australia
info@giftgadget.com.au
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
Dear Mr. Wielunski:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2716. Based on our evaluation, it appears that you have discontinued your listings for Mylanta 2go Antacid Double Strength (NDC 84177-0801) and Microlax Enema (NDC 84177-0020). 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. 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, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Content current as of:
09/23/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Medina Baking and Powder Products, Inc.
MARCS-CMS 619373 —
January 10, 2024
Delivery Method:
VIA Electronic Mail
Reference #:
24-HAFE4-WLCOL-01
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Roberto Martin
Recipient Title
President
Medina Baking and Powder Products, Inc.
1864 NW 22nd Street
Miami
,
FL
33142-7444
United States
rmartin@medinabaking.com
Issuing Office:
Office of Human and Animal Food Operations Division IV East
United States
Secondary Issuing Offices
United States
Dear Mr. Roberto Martin:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, 22-HAFE4-WL-03 dated March 4, 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/
Pearl E. Lopina -S
Pearl Lopina
Digitally signed by Pearl
E. Lopina -S Date: 2024.01.10
14:35:33 -05'00'
Director of Compliance Branch OHAFO, Division IV East
Content current as of:
01/12/2024
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Milky Way International Trading Corporation
MARCS-CMS 652935 —
May 09, 2024
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Frederick C. Chiu
Recipient Title
CEO
Milky Way International Trading Corporation
15203 Shoemaker Avenue
Norwalk
,
CA
90650-6858
United States
Issuing Office:
Division of West Coast Imports
United States
Secondary Issuing Offices
United States
Dear Mr. Chiu:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, issued April 14, 2023 (CMS # 652935). 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/
Lawton W. Lum
Director of Compliance
Division of West Coast Imports
Content current as of:
05/15/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Missouri Analytical Laboratories Inc
MARCS-CMS 615319 —
October 09, 2024
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Mr. Richard A. Gilbert
Recipient Title
President
Missouri Analytical Laboratories Inc
1820 Delmar Boulevard
Saint Louis
,
MO
63103
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
Secondary Issuing Offices
United States
Dear Mr. Gilbert:
The Food and Drug Administration has completed the evaluation of corrective actions in response to our Warning Letter (WL # 615319), dated September 30, 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 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/
Brian Nicholson
Compliance Officer
Division of Drug Quality I
Content current as of:
10/15/2024
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Nutrishus Brands Inc.
MARCS-CMS 612938 —
February 06, 2024
Product:
Dietary Supplements
Recipient:
Recipient Name
Steven Hanley
Recipient Title
CEO
Nutrishus Brands Inc.
1450 West Peachtree Street, NW #200
PMB 14642
Atlanta
,
GA
30309-2955
United States
steve@RxSugar.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Secondary Issuing Offices
United States
Dear Mr. Hanley,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #612938, issued July 28, 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 Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
02/13/2026
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Old Europe Cheese, Inc.
MARCS-CMS 644539 —
April 05, 2024
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Gilbert Bourgouin
Recipient Title
General Manager
Old Europe Cheese, Inc.
1330 E. Empire Avenue
Benton Harbor
,
MI
49022-2018
United States
gilbert@oldeuropecheese.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
Secondary Issuing Offices
United States
Dear Mr. Bourgouin:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued on March 17, 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:
04/08/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Onofrio's Fresh Cut, Inc.
MARCS-CMS 618502 —
June 28, 2024
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Richard A. Onofrio
Recipient Title
Owner/President
Onofrio's Fresh Cut, Inc.
222 Forbes Ave
New Haven
,
CT
06512
United States
Issuing Office:
Office of Human and Animal Food Operations - East Division 1
United States
Secondary Issuing Offices
United States
Dear Mr. Onofrio:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 618502, issued on January 10, 2022 for your facility located at 222 Forbes Ave, New Haven, CT 06512. 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/
Latoya Griffith
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
07/15/2024
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Organa International Corp.
MARCS-CMS 613018 —
September 30, 2024
Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Laurence M. Mills
Recipient Title
Owner
Organa International Corp.
533 N 1650 W
Springville
,
UT
84663
United States
larry@organa.net
Issuing Office:
Office of Human and Animal Food Operations Division West 4
United States
Secondary Issuing Offices
United States
Dear Mr. Mills:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS Case # 613018, 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:
10/04/2024
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Owlet Baby Care, Inc.
MARCS-CMS 616354 —
June 05, 2024
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Kurt Workman
Recipient Title
Chief Executive Officer
Owlet Baby Care, Inc.
3300 N. Ashton Blvd
Suite 300
Lehi
,
UT
84043
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
Dear Mr. Workman:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 616354, dated October 5, 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/
for Malvina B. Eydelman, M.D.
Director
OHT 1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Center for Devices and Radiological Health
Content current as of:
06/28/2024
Regulated Product(s)
Medical Devices