Summary
High-impact items this period
Fast Masks USA LLC
COVID-19 personal protective equipment adulterated and misbranded
Why: Masks marketed as COVID-19 protection without proper FDA authorization ·
Mar 26 ·
Impact: HIGH
Bouji Moj Oyeeb, Inc. d/b/a MasterMix E-Liquid
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Mar 26 ·
Impact: HIGH
Ikcon Investments, Inc dba Ikcon Medical
COVID-19 medical devices adulterated and misbranded
Why: Unapproved COVID-19 medical devices marketed with false claims ·
Mar 25 ·
Impact: HIGH
Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs
COVID-19 products adulterated and misbranded
Why: Unapproved COVID-19 testing or treatment products marketed improperly ·
Mar 24 ·
Impact: HIGH
Distribuidora Lagunera del Norte S.A. de C.V.
Multiple violations: unapproved, misbranded, adulterated pharmaceuticals
Why: Marketed finished pharmaceuticals without approval with compliance defects ·
Mar 23 ·
Impact: HIGH
Block Scientific
COVID-19 laboratory products adulterated and misbranded
Why: Unapproved COVID-19 testing products marketed improperly ·
Mar 18 ·
Impact: HIGH
Shenzhen Weifa Technology Co., Ltd
Device IDE/PMA violation with adulterated device
Why: Distributing adulterated device without proper investigational or approval status ·
Mar 11 ·
Impact: HIGH
maskshell.com
COVID-19 products adulterated and misbranded
Why: Selling unauthorized or misbranded COVID-19 related products online ·
Mar 11 ·
Impact: HIGH
Selected medium-impact items
Immune & Genetics Protocols, LLC
New drug product misbranding and unauthorized marketing
Why: Product claims exceed allowable supplement health claims under FDA regulations ·
Mar 30 ·
Impact: MEDIUM
George DeLallo Company, Inc.
Food product misbranding and labeling violations
Why: Inaccurate or inadequate product labeling and allergen declaration failures ·
Mar 30 ·
Impact: MEDIUM
Hanover Foods Corporation
Food product misbranding and labeling violations
Why: Inaccurate or inadequate product labeling and allergen declaration failures ·
Mar 26 ·
Impact: MEDIUM
Morin Enterprises Inc. d/b/a Ecig Crib
Tobacco products adulterated and misbranded
Why: Violated Tobacco Control Act through product composition and labeling ·
Mar 26 ·
Impact: MEDIUM
Global Trade Bridge Corporation
Foreign Supplier Verification Program (FSVP) non-compliance
Why: Failed to implement adequate supplier verification procedures for imports ·
Mar 25 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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