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FDA Enforcement — January 2021 Report

Automated analysis of 32 items from public government data sources. Updated daily.

Summary

32
Total items
11
High impact
21
Medium impact
0
Low impact

High-impact items this period

Carolina Vapor Mill, LLC d/b/a Carolina Vapor Mill
Tobacco product adulterated and misbranded violations unresolved
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Jan 29  ·  Impact: HIGH
Bombay Vapor LLC
Tobacco product adulterated and misbranded violations unresolved
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Jan 29  ·  Impact: HIGH
Professional Compounding Centers of America dba PCCA
CGMP violations in finished pharmaceuticals, adulterated/misbranded
Why: Manufacturing facility failed to meet Current Good Manufacturing Practice standards  ·  Jan 27  ·  Impact: HIGH
Grupo Plast-Y-Kosas, SA de CV
Unapproved new drug, misbranded, adulterated pharmaceutical violations
Why: Manufacturing/distributing unapproved drugs without proper labeling  ·  Jan 25  ·  Impact: HIGH
Ignacio Reyes Gonzalez
Unapproved new drug, misbranded, adulterated pharmaceutical violations
Why: Manufacturing/distributing unapproved drugs without proper labeling  ·  Jan 25  ·  Impact: HIGH
Laboratorios Jaloma S.A. de C.V.
Unapproved new drug, misbranded, adulterated pharmaceutical violations
Why: Manufacturing/distributing unapproved drugs without proper labeling  ·  Jan 25  ·  Impact: HIGH
Yuyao YiJia Daily Chemical Co., Ltd.
Current Good Manufacturing Practice violations in finished pharmaceuticals
Why: Failure to meet CGMP requirements for pharmaceutical manufacturing  ·  Jan 22  ·  Impact: HIGH
Allimax Us
Unapproved COVID-19 treatment claims and misbranding
Why: Marketing unapproved COVID-19 products with fraudulent health claims  ·  Jan 12  ·  Impact: HIGH
AusarHerbs
Unapproved COVID-19 treatment claims and misbranding
Why: Marketing unapproved COVID-19 products with fraudulent health claims  ·  Jan 12  ·  Impact: HIGH
Entia Biosciences, Inc
New drug product misbranded without proper FDA approval
Why: Marketing unapproved drug product with improper labeling or claims  ·  Jan 06  ·  Impact: HIGH

Selected medium-impact items

American Legends E-Liquid, LLLP
Tobacco product adulterated/misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Jan 29  ·  Impact: MEDIUM
Austin Vapor
Tobacco product adulterated/misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Jan 29  ·  Impact: MEDIUM
Chief Vapor
Tobacco product adulterated/misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Jan 29  ·  Impact: MEDIUM
Average Joes Juice LLC
Tobacco product adulterated and misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Jan 29  ·  Impact: MEDIUM
The Mad Alchemist LLC
Tobacco product adulterated and misbranded violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Jan 29  ·  Impact: MEDIUM

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Data sourced from public government APIs. AI analysis via Claude Haiku. Full methodology →