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Warning Letter

Warning Letter Records

Browse through 9,967 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 9,967 records

NuPack Inc

NuPack Inc
•
Sep 24, 2025
•ID: 4abf20b3...

Product: other

Office: Human Foods Program

People: Maria S. Knirk

Violations: 5 code(s)

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Intas Pharmaceuticals Limited

Intas Pharmaceuticals Limited
•
Sep 17, 2025
•ID: 5823afb5...

Product: drugs

Office: Center for Drug Evaluation and Research

People: Francis Godwin (Director)

Violations: 5 code(s)

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Lexia LLC

Lexia LLC
•
Sep 29, 2025
•ID: a4164f8c...

Product: drugs

Office: Center for Drug Evaluation and Research

People: Francis Godwin (Director)

Violations: 5 code(s)

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Foshan Miwei Cosmetics Co., Ltd.

Foshan Miwei Cosmetics Co., Ltd.
•
Oct 24, 2025
•ID: b1e15995...

Product: drugs

Office: Center for Drug Evaluation and Research

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

Violations: 5 code(s)

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Eaglelionton Int"l Trading Co Inc

Eaglelionton Int"l Trading Co Inc
•
Feb 12, 2026
•ID: 02b0ad5b...

Product: other

Office: Division of Northeast Imports 

People: Joseph S. Tomao (Program Division Director)

Violations: 5 code(s)

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Ten Days Manufacturing d/b/a Daily Manufacturing

Ten Days Manufacturing d/b/a Daily Manufacturing
•
Apr 1, 2026
•ID: 41157425...

Product: tobacco

Office: Office of Compliance and Enforcement

People: Ele Ibarra-Pratt

Violations: 5 code(s)

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Leltek Inc.

Leltek Inc.
•
Mar 6, 2025
•ID: a2c55ba2...

Product: devices

Office: Office of Health Technology 8 (Radiological Health)

People: Robert A. Ochs (Office Director)

Violations: 5 code(s)

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SaNOtize

SaNOtize
•
Feb 17, 2026
•ID: bf537513...

Product: drugs

Office: Office of Unapproved Drugs & Labeling Compliance

People: Tina Smith (Director)

Violations: 5 code(s)

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Pro Numb Tattoo Numbing Spray LLC

Pro Numb Tattoo Numbing Spray LLC
•
Nov 6, 2025
•ID: 0c7a1737...

Product: drugs

Office: Center for Drug Evaluation and Research

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

Violations: 5 code(s)

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vapepengood.com

vapepengood.com
•
Jan 1, 1970
•ID: f6b4cac3...

Product: tobacco

Office: Office of Compliance and Enforcement

People: Ele Ibarra-Pratt

Violations: 5 code(s)

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nicoprof.com

nicoprof.com
•
Jan 1, 1970
•ID: f533a626...

Product: tobacco

Office: Office of Compliance and Enforcement

People: Ele Ibarra-Pratt

Violations: 5 code(s)

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New Life Pharma Limited Liability Company

New Life Pharma Limited Liability Company
•
Feb 13, 2026
•ID: 9290ade5...

Product: drugs

Office: Office of Compliance

People: Jill P. Furman (Director)

Violations: 5 code(s)

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Espifresh Inc.

Espifresh Inc.
•
Jan 28, 2026
•ID: f84494f1...

Product: other

Office: Division of West Coast Imports

People: Kathleen Turner (Program Division Director)

Violations: 5 code(s)

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Apollo Care, LLC

Apollo Care, LLC
•
Mar 27, 2025
•ID: 1259d49f...

Product: drugs

Office: Office of Compounding Quality and Compliance

People: Matthew J. Lash (Acting Director)

Violations: 5 code(s)

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Par Health USA, LLC & Endo USA, Inc.

Par Health USA, LLC & Endo USA, Inc.
•
Oct 20, 2025
•ID: 32bab0b6...

Product: drugs

Office: Center for Drug Evaluation and Research

People: Francis Godwin (Director)

Violations: 5 code(s)

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UCSF Radiopharmaceutical Facility

UCSF Radiopharmaceutical Facility
•
Jul 24, 2025
•ID: 4f8e9285...

Product: drugs

Office: Center for Drug Evaluation and Research

People: Francis Godwin (Director)

Violations: 5 code(s)

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RC Outsourcing, LLC

RC Outsourcing, LLC
•
Aug 28, 2025
•ID: 744e0738...

Product: drugs

Office: Center for Drug Evaluation and Research

People: Francis Godwin (Director)

Violations: 5 code(s)

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Thrive Health and Wellness, LLC, dba Thrive Health Solutions

Thrive Health and Wellness, LLC, dba Thrive Health Solutions
•
Apr 3, 2025
•ID: aaf0ca4d...

Product: drugs

Office: Office of Compounding Quality and Compliance

People: Matthew J. Lash (Acting Director)

Violations: 5 code(s)

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shopcalismokes.com

shopcalismokes.com
•
Jan 1, 1970
•ID: d8f5fafa...

Product: tobacco

Office: Office of Compliance and Enforcement

People: Ele Ibarra-Pratt

Violations: 5 code(s)

View Details

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
•
Aug 15, 2025
•ID: af01f312...

Product: drugs

Office: Center for Drug Evaluation and Research

People: Francis Godwin (Director)

Violations: 5 code(s)

View Details
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