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FDA Enforcement — October 2025 Report

Automated analysis of 33 items from public government data sources. Updated daily.

Summary

33
Total items
9
High impact
24
Medium impact
0
Low impact

High-impact items this period

Apotex Inc.
Pharmaceutical adulteration CGMP violations
Why: Current Good Manufacturing Practice violations in finished drugs  ·  Oct 31  ·  Impact: HIGH
Liebel-Flarsheim Company LLC
Pharmaceutical adulteration CGMP violations
Why: Current Good Manufacturing Practice violations in finished drugs  ·  Oct 17  ·  Impact: HIGH
The Tranzonic Companies/Innocore Sales & Marketing Inc.
CGMP violations in adulterated finished pharmaceutical production
Why: Manufacturing process deviations compromising product purity and safety  ·  Oct 16  ·  Impact: HIGH
Scientific Protein Laboratories, LLC
Active pharmaceutical ingredient adulteration CGMP violations
Why: Current Good Manufacturing Practice violations in API production  ·  Oct 10  ·  Impact: HIGH
Foshan Yiying Hygiene Products Co., Ltd.
CGMP violations in adulterated finished pharmaceutical production
Why: Manufacturing process deviations compromising product purity and safety  ·  Oct 10  ·  Impact: HIGH
Acme United Corporation
CGMP violations in adulterated finished pharmaceutical production
Why: Manufacturing process deviations compromising product purity and safety  ·  Oct 10  ·  Impact: HIGH
www.usmedschoice.com
Unapproved new drugs marketed with misbranding
Why: Distribution of drugs lacking FDA approval with false labeling claims  ·  Oct 06  ·  Impact: HIGH
Qianjiang Kingphar Medical Material Co Ltd.
Medical device adulteration and misbranding violations
Why: CGMP/QSR non-compliance in medical device manufacturing  ·  Oct 03  ·  Impact: HIGH
Contec Medical Systems Co., Ltd.
Medical device adulteration CGMP violations
Why: Current Good Manufacturing Practice violations in device production  ·  Oct 02  ·  Impact: HIGH

Selected medium-impact items

tjsintorrance.net
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Oct 24  ·  Impact: MEDIUM
spacepuffbar.com
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Oct 24  ·  Impact: MEDIUM
MG GROUP USA
Foreign supplier verification program non-compliance
Why: Inadequate supplier verification procedures for imported food products  ·  Oct 23  ·  Impact: MEDIUM
Kure Corporation
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Oct 23  ·  Impact: MEDIUM
Kure Vaporium & Lounge
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Oct 23  ·  Impact: MEDIUM

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Data sourced from public government APIs. AI analysis via Claude Haiku. Full methodology →