Summary
High-impact items this period
MONQ, LLC
Finished pharmaceutical marketed as unapproved new drug
Why: Marketing aromatic products with drug/therapeutic claims without approval ·
Jun 30 ·
Impact: HIGH
Herbsens Botanicals
Finished pharmaceutical marketed as unapproved new drug
Why: Marketing botanical products with drug claims without FDA approval ·
Jun 30 ·
Impact: HIGH
Klarity Kratom
Finished pharmaceutical marketed as unapproved new drug
Why: Marketing kratom with disease claims without FDA approval ·
Jun 30 ·
Impact: HIGH
Kratom Exchange
Finished pharmaceutical marketed as unapproved new drug
Why: Marketing kratom with disease claims without FDA approval ·
Jun 30 ·
Impact: HIGH
Omni Consumer Products LLC d/b/a YoKratom
Finished pharmaceutical marketed as unapproved new drug
Why: Marketing kratom with disease claims without FDA approval ·
Jun 30 ·
Impact: HIGH
W.H.P.M, Inc.
Unapproved COVID-19 related medical device products marketed
Why: Unauthorized marketing of medical devices for pandemic treatment ·
Jun 30 ·
Impact: HIGH
Imprimis Rx LLC
False misleading claims and misbranded pharmaceutical products
Why: Making unsubstantiated health claims in marketing materials ·
Jun 30 ·
Impact: HIGH
Bioiberica, SAU
CGMP violations in API manufacturing resulting in adulteration
Why: Failed to maintain current Good Manufacturing Practices for active pharmaceutical ingredients ·
Jun 30 ·
Impact: HIGH
Bi-Coastal Pharma International
Pharmaceutical CGMP adulteration violations detected
Why: Failure to maintain current good manufacturing practices for finished pharmaceuticals ·
Jun 30 ·
Impact: HIGH
Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V.
Unapproved, misbranded, and adulterated pharmaceutical products
Why: Marketing non-compliant pharmaceuticals through media platform ·
Jun 27 ·
Impact: HIGH
Selected medium-impact items
Vaping Delights LLC
Tobacco products adulterated and misbranded in violation of FSPTCA
Why: Non-compliant vape products marketed without proper regulatory approval ·
Jun 30 ·
Impact: MEDIUM
Elk River Vapor Shop
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jun 28 ·
Impact: MEDIUM
VAPORIZIT LLC
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jun 28 ·
Impact: MEDIUM
Regino Produce LLC
FSVP violations in foreign supplier verification program
Why: Failure to adequately verify foreign produce suppliers ·
Jun 27 ·
Impact: MEDIUM
Flores Produce, Inc.
FSVP violations in foreign produce supplier verification
Why: Inadequate procedures for verifying foreign produce suppliers ·
Jun 24 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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