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FDA Enforcement — October 2022 Report

Automated analysis of 42 items from public government data sources. Updated daily.

Summary

42
Total items
26
High impact
16
Medium impact
0
Low impact

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. Full methodology →