Summary
High-impact items this period
Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com
COVID-19 products adulterated and misbranded
Why: Selling misbranded or unapproved COVID-19 medical masks and products ·
May 28 ·
Impact: HIGH
Irvin, Inc.
Adulterated and misbranded COVID-19 related products
Why: Manufacturing and distributing unapproved coronavirus products without proper authorization ·
May 27 ·
Impact: HIGH
Dongguan City Xinyuan Nonwoven Co., Ltd.
Investigational device adulteration in IDE/PMA applications
Why: Supplying adulterated materials for investigational or approved medical devices ·
May 27 ·
Impact: HIGH
JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
New drug product misbranded and marketed without approval
Why: Unauthorized health claims and marketing of unapproved drug product ·
May 26 ·
Impact: HIGH
Mask Supply Store
Investigational device adulteration in IDE/PMA applications
Why: Distributing adulterated masks under investigational device exemption pathways ·
May 21 ·
Impact: HIGH
Vape Lizard E-Juice LLC
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
May 21 ·
Impact: HIGH
Big Chief Vapor Products LLC
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
May 20 ·
Impact: HIGH
Smart Women's Choice
Unapproved new drug marketed as finished pharmaceutical
Why: Selling unapproved drug products without FDA approval ·
May 19 ·
Impact: HIGH
BGP, LLC
Unapproved and misbranded COVID-19 products
Why: Marketing unapproved products as COVID-19 treatments or preventatives ·
May 19 ·
Impact: HIGH
Blue Eyed Vapor
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
May 14 ·
Impact: HIGH
Selected medium-impact items
NS Products, Inc.
New drug product misbranded without FDA approval
Why: Product marketed as drug without required FDA approval ·
May 20 ·
Impact: MEDIUM
McElroy Imports
Foreign supplier verification program non-compliance
Why: Inadequate verification procedures for foreign food suppliers ·
May 12 ·
Impact: MEDIUM
The Smoker's Alternative
Selling adulterated, misbranded tobacco products in violation of act
Why: Distributing tobacco/nicotine products without proper FDA compliance or authorization ·
May 11 ·
Impact: MEDIUM
Great Lakes Gelatin Company
New drug misbranded and marketed without approval
Why: Product marketed as drug without required FDA approval ·
May 10 ·
Impact: MEDIUM
JP & SN Enterprises Inc. d/b/a eCigs International
Distributing misbranded adulterated tobacco control act violation products
Why: Selling vaping products without required FDA compliance and authorization ·
May 07 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
Full methodology →