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Warning Letter

Warning Letter Records

Browse through 10,185 warning letter records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.

Warning Letter Records

Showing 20 of 10,185 records

Tex-Stein Dairy

Tex-Stein Dairy
•
Feb 19, 2026
•ID: 6d417c8e...

Product: veterinary

Office: Center for Veterinary Medicine

People: Isaac K. Carney, Janet Mcginn, Keelan Yoder

Violations: 5 code(s)

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Lico Industries, LLC., d.b.a. American Towelette Company

Lico Industries, LLC., d.b.a. American Towelette Company
•
Feb 19, 2026
•ID: b002c78e...

Product: drugs

Office: Center for Drug Evaluation and Research

People: Francis Godwin (Director)

Violations: 5 code(s)

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FairyGene Inc

FairyGene Inc
•
Jan 15, 2026
•ID: 82d6f158...

Product: drugs

Office: Office of Manufacturing Quality

People: Francis Godwin (Director), Tina Smith (Director)

Violations: 5 code(s)

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ACCRA SUPERMARKET LLC

ACCRA SUPERMARKET LLC
•
Feb 18, 2026
•ID: 25e7c946...

Product: Food

Office: Division of Northeast Imports 

People: Joseph S. Tomao (Program Division Director)

Violations: 5 code(s)

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OC Raw Dog LLC

OC Raw Dog LLC
•
Aug 29, 2025
•ID: 2a210cfd...

Product: veterinary

Office: Center for Veterinary Medicine

People: Isaac K. Carney

Violations: 4 code(s)

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Quantum Star LLC

Quantum Star LLC
•
Mar 10, 2026
•ID: bb00517a...

Product: Food

Office: Division of West Coast Imports

People: Kathleen Turner (Program Division Director)

Violations: 5 code(s)

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NexCell Scientific Inc

NexCell Scientific Inc
•
Feb 5, 2026
•ID: 57dbc48e...

Product: biologics

Office: Center for Biologics Evaluation and Research

People: Vincent Amatrudo

Violations: 5 code(s)

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kdc/one Chatsworth, Inc.

kdc/one Chatsworth, Inc.
•
Apr 3, 2026
•ID: a3082184...

Product: drugs

Office: Center for Drug Evaluation and Research

People: Francis Godwin (Director)

Violations: 5 code(s)

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LDNN Produce Inc.

LDNN Produce Inc.
•
May 27, 2026
•ID: 6b8016b7...

Product: Food

Office: Division of Northeast Imports 

People: Joseph S. Tomao (Program Division Director)

Violations: 5 code(s)

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Empower Clinic Services, LLC dba Empower Pharmacy

Empower Clinic Services, LLC dba Empower Pharmacy
•
Nov 14, 2025
•ID: 29402bea...

Product: drugs

Office: Center for Drug Evaluation and Research

People: Clint L. Narver (Director)

Violations: 5 code(s)

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Pensar Medical LLC

Pensar Medical LLC
•
Apr 28, 2026
•ID: d70e6750...

Product: devices

Office: Center for Devices and Radiological Health

People: Barbara A. Marsden (Acting Director)

Violations: 5 code(s)

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BioDrive, Inc.

BioDrive, Inc.
•
Aug 3, 2026
•ID: a2718c30...

Product: Dietary Supplements

Office: Human Foods Program

People: Maria S. Knirk

Violations: 5 code(s)

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OHOM PADMAAVATHII LLC

OHOM PADMAAVATHII LLC
•
Jan 6, 2026
•ID: 6c1f7ea9...

Product: Food

Office: Division of Northeast Imports 

People: Joseph S. Tomao (Program Division Director)

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SHOULY IMPORT CORP

SHOULY IMPORT CORP
•
Apr 30, 2026
•ID: 711a6866...

Product: Food

Office: Division of Northeast Imports 

People: Joseph S. Tomao (Program Division Director)

Violations: 5 code(s)

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UNION TRADE INC

UNION TRADE INC
•
Apr 7, 2026
•ID: dc992d73...

Product: Food

Office: Division of West Coast Imports

People: Kathleen Turner (Program Division Director)

Violations: 5 code(s)

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RAAW Energy

RAAW Energy
•
Jan 22, 2026
•ID: 564cacca...

Product: veterinary

Office: Center for Veterinary Medicine

People: Kitt A. Schulman, Isaac K. Carney

Violations: 5 code(s)

View Details

Binh Minh Tofu

Binh Minh Tofu
•
Mar 6, 2026
•ID: 1f0b12e3...

Product: Food

Office: Human Foods Program

People: Maria S. Knirk

Violations: 5 code(s)

View Details

Specialty Health Products Inc

Specialty Health Products Inc
•
Dec 11, 2025
•ID: 57b136aa...

Product: devices

Office: Center for Devices and Radiological Health

People: Cesar A. Perez (Acting Deputy Director)

Violations: 5 code(s)

View Details

YAM MAN FOODS LLC

YAM MAN FOODS LLC
•
Apr 23, 2026
•ID: 3fd234ad...

Product: Food

Office: Division of Northeast Imports 

People: Marvin A. Marenco, Joseph S. Tomao (Program Division Director), Seymour D. Wilson

Violations: 5 code(s)

View Details

Advance-Esthetic LLC

Advance-Esthetic LLC
•
Nov 6, 2025
•ID: 86f343eb...

Product: devices

Office: Center for Devices and Radiological Health

People: Kostiantyn Suichmez, Melissa I. Michurski, Rafael Padilla (Compliance Officer-Medical Devices)

Violations: 5 code(s)

View Details
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