Summary
High-impact items this period
Abraxis Bioscience LLC
Finished pharmaceutical manufacturing CGMP violations
Why: Adulterated drug products from manufacturing deficiencies ·
Oct 31 ·
Impact: HIGH
Latin Foods Market
Unapproved and misbranded pharmaceutical products sold
Why: Selling unapproved new drugs without FDA authorization ·
Oct 28 ·
Impact: HIGH
Amazon.com, Inc.
Unapproved new drug marketed and misbranded
Why: Marketplace hosted unapproved drugs with false health claims ·
Oct 28 ·
Impact: HIGH
Walmart Inc.
Unapproved and misbranded pharmaceutical products sold
Why: Selling unapproved new drugs without FDA authorization ·
Oct 28 ·
Impact: HIGH
Happy Sprout Inc.
CGMP violations with insanitary manufacturing conditions
Why: Failure to maintain Current Good Manufacturing Practice standards ·
Oct 27 ·
Impact: HIGH
Titans Global Inc.
Failed to implement Foreign Supplier Verification Program
Why: Inadequate foreign supplier verification procedures and documentation ·
Oct 27 ·
Impact: HIGH
Lakpura LLC
Unapproved and misbranded COVID-19 products
Why: Marketing products without FDA approval during pandemic ·
Oct 24 ·
Impact: HIGH
Cryos International USA LLC
HCT/P regulatory deviations and CFR non-compliance
Why: Non-compliance with human cells/tissues product regulations ·
Oct 24 ·
Impact: HIGH
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC
Compounding pharmacy producing adulterated drug products
Why: Failure to maintain sterility and safety in compounding operations ·
Oct 21 ·
Impact: HIGH
Island Ecig & Vape Co
Tobacco product adulterated or misbranded under FSPTCA
Why: Failure to comply with Family Smoking Prevention and Tobacco Control Act requirements ·
Oct 19 ·
Impact: HIGH
Selected medium-impact items
Sabrina Cosmetics d/b/a SCOS
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Smoking Prevention and Tobacco Control Act ·
Oct 28 ·
Impact: MEDIUM
Vape Crusades
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Oct 28 ·
Impact: MEDIUM
Lucero Produce II Corp.
Foreign supplier verification program compliance failures
Why: Inadequate verification of foreign food suppliers ·
Oct 26 ·
Impact: MEDIUM
180 Vape E-Cigs & Lounge
Tobacco products adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Oct 26 ·
Impact: MEDIUM
Juicemafia Inc. d/b/a ECIG-Works
Tobacco products adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act ·
Oct 26 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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