Summary
High-impact items this period
Amneal Pharmaceuticals, LLC
CGMP violations in finished pharmaceutical manufacturing
Why: FDA inspection identified adulterated drug product standards ·
Aug 27 ·
Impact: HIGH
ejuices.com
Tobacco product adulterated and misbranded violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Aug 27 ·
Impact: HIGH
Trew Balance
Unapproved ophthalmic drug products marketed illegally
Why: Marketing unapproved new drug products without FDA approval ·
Aug 25 ·
Impact: HIGH
Tan Nam Corporation
Food prepared or held under insanitary conditions
Why: Inadequate sanitation controls in food manufacturing or storage ·
Aug 25 ·
Impact: HIGH
Supply Center USA
Unapproved ophthalmic drug products marketed illegally
Why: Marketing unapproved new drug products without FDA approval ·
Aug 25 ·
Impact: HIGH
Mel Honey US
Unapproved ophthalmic drug products marketed illegally
Why: Marketing unapproved new drug products without FDA approval ·
Aug 25 ·
Impact: HIGH
Green Vitality dba Gr33n
Unapproved ophthalmic drug products marketed illegally
Why: Marketing unapproved new drug products without FDA approval ·
Aug 25 ·
Impact: HIGH
Life Enthusiast Co-op
Unapproved ophthalmic drug products marketed illegally
Why: Marketing unapproved new drug products without FDA approval ·
Aug 25 ·
Impact: HIGH
The Richline Group, Inc.
Medical device lacks PMA and/or 510(k) approval
Why: Device marketed without required FDA premarket approval or clearance ·
Aug 25 ·
Impact: HIGH
My Holistic Honey c/o Shenzhen Qanhai Wanb Express Supply Chain Co., LTD
Unapproved ophthalmic drug products marketed illegally
Why: Marketing unapproved new drug products without FDA approval ·
Aug 25 ·
Impact: HIGH
Selected medium-impact items
911 Vapor Inc
Tobacco product adulterated or misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Aug 28 ·
Impact: MEDIUM
Xhale Vapor N Smoke
Tobacco product adulterated or misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Aug 28 ·
Impact: MEDIUM
HS GLOBAL DISTRIBUTION LLC, d/b/a O&Z WHOLESALE
Tobacco product adulterated or misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Aug 28 ·
Impact: MEDIUM
Atomic Vapor LLC
Tobacco product adulterated or misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Aug 28 ·
Impact: MEDIUM
chillzoneusa.com
Tobacco product adulterated or misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Aug 27 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →