Summary
High-impact items this period
Skull and Roses Juice Co. LLC
Tobacco product adulterated and misbranded violation
Why: Product does not comply with Family Smoking Prevention and Tobacco Control Act ·
Dec 30 ·
Impact: HIGH
Genesis Partnership Company SA
Drug product misbranding violations
Why: Misbranded pharmaceutical product distribution and marketing ·
Dec 29 ·
Impact: HIGH
Varigard, LLC
Unapproved COVID-19 drug products marketed illegally
Why: Marketing unapproved new drug products for COVID-19 treatment ·
Dec 29 ·
Impact: HIGH
Health Plus Inc.
CGMP violations in finished pharmaceutical manufacturing
Why: Non-compliance with current good manufacturing practices ·
Dec 29 ·
Impact: HIGH
Bogart Enterprises LLC d/b/a The Vapor Shop
Tobacco product adulterated and misbranded in violation of tobacco control act
Why: E-liquid products not in compliance with Family Smoking Prevention and Tobacco Control Act ·
Dec 27 ·
Impact: HIGH
Vasyl Melnyk, M.D.
Institutional Review Board procedures and oversight violations
Why: Failure to comply with IRB requirements in bioresearch monitoring ·
Dec 21 ·
Impact: HIGH
Sunstar Americas, Inc.
Medical device CGMP and quality system regulation violations
Why: Current Good Manufacturing Practice and Quality System Regulation failures ·
Dec 21 ·
Impact: HIGH
Lady Boss Vapor Inc.
Tobacco product adulterated and misbranded in violation of tobacco control act
Why: E-liquid products not in compliance with Family Smoking Prevention and Tobacco Control Act ·
Dec 21 ·
Impact: HIGH
Frozen Wheels, LLC
Drug product adulterated manufacturing violation
Why: Pharmaceutical product failed quality or purity standards in manufacturing ·
Dec 20 ·
Impact: HIGH
Cosmic Fog Vapors Operating Company, LLC
Tobacco product adulterated and misbranded in violation of tobacco control act
Why: E-liquid products not in compliance with Family Smoking Prevention and Tobacco Control Act ·
Dec 20 ·
Impact: HIGH
Selected medium-impact items
Aroma Imports, Inc.
Foreign supplier verification program non-compliance
Why: Inadequate supplier verification procedures ·
Dec 23 ·
Impact: MEDIUM
Euphrates Foods, LLC dba Labeeb Alani Inc.
Non-compliance with Foreign Supplier Verification Program
Why: Failure to adequately verify safety of imported food products ·
Dec 23 ·
Impact: MEDIUM
Slam Cake Vapes LLC
Tobacco product adulterated and misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Dec 20 ·
Impact: MEDIUM
Teahouse Tapioca and Tea Inc.
Inadequate foreign supplier verification procedures
Why: Failure to implement required Foreign Supplier Verification Program ·
Dec 20 ·
Impact: MEDIUM
Liquid Vapor Lounge, LLC
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Dec 17 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →