⚠ You're viewing a report from May 2025. Subscribe to get the latest →

FDA Enforcement — May 2025 Report

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

Summary

33
Total items
18
High impact
15
Medium impact
0
Low impact

High-impact items this period

Nefeteri Wellness
Unapproved new drugs marketed without FDA authorization
Why: Selling drug products lacking required FDA approval  ·  May 30  ·  Impact: HIGH
Marin Baking LLC
Food prepared, packed, held under insanitary conditions
Why: Facility sanitation deficiencies in bakery operations  ·  May 28  ·  Impact: HIGH
Voehlganic Farm LLC
Shell egg production adulteration and safety violations
Why: Non-compliance with PHS Act shell egg safety regulations  ·  May 28  ·  Impact: HIGH
Aju Pharm Co., Ltd.
Medical device CGMP/QSR violations; adulterated products
Why: Manufacturing quality system deficiencies in device production  ·  May 21  ·  Impact: HIGH
denverelectroniccigarettes.com
Tobacco products adulterated and misbranded violating control act
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act regulations  ·  May 16  ·  Impact: HIGH
AACE Pharmaceuticals, Inc.
CGMP violations in finished pharmaceutical manufacturing
Why: Adulterated pharmaceuticals due to manufacturing quality failures  ·  May 13  ·  Impact: HIGH
Kabe Labortechnik GmbH
CGMP/QSR violations in medical device manufacturing
Why: Adulterated medical devices due to quality system deficiencies  ·  May 09  ·  Impact: HIGH
NeuroSync, Inc.
Medical device CGMP and QSR adulteration violations
Why: Quality System Regulation and manufacturing practice failures in device production  ·  May 09  ·  Impact: HIGH
Microspecialties, LLC
Medical device CGMP and QSR adulteration violations
Why: Quality System Regulation and manufacturing practice failures in device production  ·  May 08  ·  Impact: HIGH
Product Society LLC
Finished pharmaceutical CGMP adulteration violations
Why: Current Good Manufacturing Practice violations in pharmaceutical manufacturing processes  ·  May 08  ·  Impact: HIGH

Selected medium-impact items

Bad Drip Labs Inc.
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  May 29  ·  Impact: MEDIUM
Grow Gold Land, Inc.
Foreign supplier verification program non-compliance
Why: Inadequate verification of imported food suppliers  ·  May 27  ·  Impact: MEDIUM
Kure CBD & Vape
Tobacco product violations including adulteration and misbranding
Why: Violation of Family Smoking Prevention and Tobacco Control Act  ·  May 22  ·  Impact: MEDIUM
Artisan Vapor Company
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  May 22  ·  Impact: MEDIUM
vapordna.com
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  May 16  ·  Impact: MEDIUM

Get this delivered every week

Free tier: 3 items per vertical. Full access with paid subscription.

Subscribe — $29/mo →

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