Summary
High-impact items this period
PowerAll Pharma
Unapproved new drug marketed as finished pharmaceutical
Why: Selling unapproved drug products without FDA approval ·
Aug 31 ·
Impact: HIGH
New York Nutrition Company / American Metabolix
Unapproved new drugs marketed with false health claims
Why: Marketing dietary supplement products as unapproved drugs without FDA authorization ·
Aug 31 ·
Impact: HIGH
Flawless Labs, Inc. d/b/a Flawless Vape Shop
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Aug 27 ·
Impact: HIGH
Seditious Vapours, LLC d/b/a Butt Out Labs
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Aug 27 ·
Impact: HIGH
Fibromyalgia Treatment Group - FTG, LLC
Unapproved new drug product with misbranded claims
Why: Marketing pharmaceutical treatment without FDA approval or proper labeling ·
Aug 26 ·
Impact: HIGH
Infusion Options, Inc.
Compounding pharmacy producing adulterated drug products
Why: Non-compliance with pharmaceutical compounding quality and safety standards ·
Aug 26 ·
Impact: HIGH
Kaleido Biosciences, Inc.
Bioresearch monitoring program non-compliance
Why: Clinical trial or biomedical research monitoring violations ·
Aug 26 ·
Impact: HIGH
Adamson Analytical Laboratories, Inc.
Adulterated finished pharmaceuticals CGMP violation
Why: Current Good Manufacturing Practice non-compliance in pharmaceutical production ·
Aug 17 ·
Impact: HIGH
Akshar Sales LLC
Foreign supplier verification program non-compliance
Why: Inadequate foreign supplier verification procedures for imported products ·
Aug 16 ·
Impact: HIGH
Tropicosmeticos SA de CV
Finished pharmaceutical unapproved drug and misbranding
Why: Distributing unapproved pharmaceutical products internationally ·
Aug 10 ·
Impact: HIGH
Selected medium-impact items
Kaleidoscope Custom Vapor Lounge, LLC
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Aug 31 ·
Impact: MEDIUM
Ebenezer International Food, LLC
Foreign supplier verification program compliance failure
Why: Inadequate verification procedures for foreign food suppliers ·
Aug 30 ·
Impact: MEDIUM
Vape King Inc.
Tobacco Act violation with adulterated and misbranded products
Why: Non-compliant tobacco vaping product distribution or marketing ·
Aug 16 ·
Impact: MEDIUM
MadTown Vapor LLC
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements ·
Aug 13 ·
Impact: MEDIUM
D&C Beckley, Inc d/b/a Kickin’ Ash Vapors
Tobacco Act violation with adulterated and misbranded products
Why: Non-compliant tobacco vaping product manufacturing or sales ·
Aug 12 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →