Summary
High-impact items this period
NeuroField, Inc.
Adulterated investigational/premarket approval device violations
Why: Manufacturing adulterated device under IDE or PMA applications ·
Feb 28 ·
Impact: HIGH
Ivermectin24h.com
Unlawful sale of misbranded drugs over internet
Why: Selling unapproved ivermectin products without FDA authorization ·
Feb 25 ·
Impact: HIGH
N3Vapor, LLC Kill Devil Hills
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Feb 25 ·
Impact: HIGH
ECBlend LLC
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Feb 25 ·
Impact: HIGH
Accu Bio-Chem Laboratories
Finished pharmaceutical adulteration and CGMP non-compliance
Why: Failure to maintain current Good Manufacturing Practices standards ·
Feb 24 ·
Impact: HIGH
MYA International, Inc.
Unapproved new drugs marketed and misbranded
Why: Marketing drugs without required FDA approval or authorization ·
Feb 24 ·
Impact: HIGH
My Natural Treatment
Unapproved and misbranded COVID-19 related products marketed
Why: False marketing of unapproved products as COVID-19 treatments ·
Feb 22 ·
Impact: HIGH
Lusys Laboratories, Inc.
COVID-19 device adulteration and misbranding violations
Why: Manufacturing adulterated or misbranded COVID-19 related products ·
Feb 17 ·
Impact: HIGH
Twisted Vapors
Tobacco product adulterated and misbranded violations unresolved
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Feb 17 ·
Impact: HIGH
Vital Health & Wellness
Unapproved new drug products misbranded and marketed
Why: Marketing of unapproved pharmaceutical products with false therapeutic claims ·
Feb 17 ·
Impact: HIGH
Selected medium-impact items
Pet Center, Inc.
Animal food adulteration and insanitary preparation conditions
Why: CGMP violations causing food contamination and safety risks ·
Feb 28 ·
Impact: MEDIUM
Sabine S. Hazan, M.D.
Clinical investigator protocol violations and compliance issues
Why: Non-compliance with clinical investigator regulations and requirements ·
Feb 28 ·
Impact: MEDIUM
Fella Group LLC
Foreign supplier verification program non-compliance
Why: Inadequate supplier assessment or verification documentation ·
Feb 25 ·
Impact: MEDIUM
Vape House
Tobacco products adulterated and misbranded under FSPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Feb 24 ·
Impact: MEDIUM
Vapor Corner Inc
Tobacco products adulterated and misbranded under FSPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Feb 24 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →