Summary
High-impact items this period
Tasty Vape Shop
Tobacco product adulterated and misbranded violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jun 30 ·
Impact: HIGH
TNT Vapors
Tobacco product adulterated and misbranded violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Jun 30 ·
Impact: HIGH
Fixture Display LLC
Device IDE/PMA violation with adulterated device
Why: Distributing adulterated device without proper approval or investigational status ·
Jun 28 ·
Impact: HIGH
Davati Medical Supply LLC
Unapproved influenza virus product marketed
Why: Distributing unapproved and misbranded influenza-related medical product ·
Jun 25 ·
Impact: HIGH
Great Healthworks, Inc.
Unapproved new drugs marketed and misbranded
Why: Selling unapproved pharmaceutical products without proper authorization ·
Jun 23 ·
Impact: HIGH
Aquavit Pharmaceuticals, Inc
Device IDE/PMA violation without proper authorization
Why: Conducting investigational device testing without approved exemption or PMA ·
Jun 17 ·
Impact: HIGH
Novel Laboratories, Inc. d.b.a LUPIN
CGMP violation in finished pharmaceutical manufacturing
Why: Failure to maintain current good manufacturing practices for pharmaceuticals ·
Jun 11 ·
Impact: HIGH
Flora Inc
New drug product marketed without approval, misbranded
Why: Unauthorized marketing of unapproved pharmaceutical/drug product ·
Jun 07 ·
Impact: HIGH
Amplicon Land, LLC
COVID-19 products adulterated and misbranded
Why: Marketing unauthorized or misbranded COVID-19 prevention/treatment products ·
Jun 07 ·
Impact: HIGH
Zhejiang Xichen Medical Technology Co., Ltd.
Device IDE/PMA violation without proper authorization
Why: Conducting investigational device activities without approved IDE or PMA ·
Jun 04 ·
Impact: HIGH
Selected medium-impact items
Green City Distribution
Non-compliance with Foreign Supplier Verification Program requirements
Why: Insufficient supplier verification and control procedures for imported products ·
Jun 30 ·
Impact: MEDIUM
Dry Produce Division USA LLC
Foreign supplier verification program non-compliance
Why: Inadequate verification controls for imported produce suppliers ·
Jun 30 ·
Impact: MEDIUM
FMT Services, LLC
Foreign supplier verification program non-compliance
Why: Inadequate verification of foreign food suppliers and imports ·
Jun 29 ·
Impact: MEDIUM
Kuiyi International Inc.
Foreign supplier verification program non-compliance
Why: Inadequate supplier verification protocols for imported food or products ·
Jun 29 ·
Impact: MEDIUM
World Packaging Solutions, LLC
Investigational device adulteration in IDE/PMA applications
Why: Providing adulterated packaging materials for investigational medical devices ·
Jun 28 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →