Summary
High-impact items this period
Ole Smoky Candy Kitchen Factory
Food manufacturing facility operating under insanitary CGMP conditions
Why: Non-compliance with current good manufacturing practices for food ·
Jul 30 ·
Impact: HIGH
Lepu Medical Technology -Beijing- Co., Ltd.
Adulterated and misbranded COVID-19 medical devices
Why: Marketing unapproved COVID-19 diagnostic devices with false claims ·
Jul 29 ·
Impact: HIGH
1st Phorm LLC
Unapproved new drugs and misbranded supplement products
Why: Making unauthorized drug claims on dietary supplements ·
Jul 29 ·
Impact: HIGH
Farmakeio Outsourcing LLC
Adulterated drug products from compounding pharmacy operations
Why: Failure to maintain proper compounding pharmacy standards and quality controls ·
Jul 29 ·
Impact: HIGH
Dr. Thomas Polucki Upper Cervical Chiropractic, Inc.
Unapproved and misbranded COVID-19 related products
Why: Marketing unauthorized COVID-19 treatments or preventatives ·
Jul 28 ·
Impact: HIGH
Sanit Technologies, LLC dba Durisan
Adulterated finished pharmaceutical products
Why: Non-compliance with Current Good Manufacturing Practice standards ·
Jul 27 ·
Impact: HIGH
Lexion Medical LLC
Adulterated and misbranded COVID-19 related medical products
Why: Unauthorized marketing of unapproved medical devices and diagnostics ·
Jul 26 ·
Impact: HIGH
Vivera Pharmaceuticals, Inc.
Adulterated and misbranded COVID-19 pharmaceutical products
Why: Marketing unapproved COVID-19 treatments with false efficacy claims ·
Jul 26 ·
Impact: HIGH
Vapor Amor
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 ·
Jul 23 ·
Impact: HIGH
MB Solutions, LLC/BioSpectrum CBD
Unapproved and misbranded CBD products marketed as drugs
Why: Distribution of cannabidiol products without proper FDA approval or authorization ·
Jul 22 ·
Impact: HIGH
Selected medium-impact items
Bradley Jaramillo LLC d/b/a Trinity Vapor Lounge
Adulterated and misbranded tobacco products
Why: Failure to comply with Family Smoking Prevention and Tobacco Control Act ·
Jul 30 ·
Impact: MEDIUM
The Vapor Hutt
Adulterated and misbranded tobacco/vapor products
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jul 30 ·
Impact: MEDIUM
Visible Vapors, LLC
Adulterated and misbranded tobacco/vapor products
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act regulations ·
Jul 28 ·
Impact: MEDIUM
Roal Produce, Inc
Failure to comply with Foreign Supplier Verification Program
Why: Inadequate supplier verification procedures for imported food products ·
Jul 27 ·
Impact: MEDIUM
Trekker Vapors LLP
Adulterated and misbranded tobacco products
Why: Violation of Family Smoking Prevention and Tobacco Control Act requirements ·
Jul 23 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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