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FDA Enforcement — November 2021 Report

Automated analysis of 46 items from public government data sources. Updated daily.

Summary

46
Total items
40
High impact
6
Medium impact
0
Low impact

High-impact items this period

Dental Technologies Inc.
Medical device CGMP and QSR violations, product adulteration
Why: Manufacturing and quality system failures in dental devices  ·  Nov 30  ·  Impact: HIGH
Tampa Vapor Inc.
Tobacco products adulterated or misbranded under FSPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Nov 30  ·  Impact: HIGH
KC Vape LLC
Tobacco product adulterated or misbranded in violation of FSPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Nov 30  ·  Impact: HIGH
Desert Vapors LLC
Tobacco product adulterated or misbranded in violation of FSPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Nov 30  ·  Impact: HIGH
The Zen Vaper E-Liquids, LLC
Tobacco product adulterated or misbranded in violation of FSPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Nov 29  ·  Impact: HIGH
Sanitor Corporation
Pharmaceutical CGMP violations and product adulteration
Why: Current Good Manufacturing Practice deviations in finished pharmaceuticals  ·  Nov 29  ·  Impact: HIGH
DSAART, LLC. dba Alpha Aesthetics
Medical device manufacturing deficiency in CGMP and quality system requirements
Why: Quality system failures in device manufacture packing storage and installation  ·  Nov 24  ·  Impact: HIGH
Verdict Brands, LLC d/b/a Verdict Vapors, LLC
Tobacco product adulterated or misbranded in violation of FSPTCA
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Nov 24  ·  Impact: HIGH
LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA
New drug marketed without approval and misbranded
Why: Marketing unapproved pharmaceutical products with drug claims  ·  Nov 23  ·  Impact: HIGH
Induction Therapies, LLC
Adulterated medical device without IDE or PMA approval
Why: Manufacturing investigational devices outside approved protocol  ·  Nov 23  ·  Impact: HIGH

Selected medium-impact items

JMJ Howard Enterprises, Inc. d/b/a Netvapes
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention Act  ·  Nov 24  ·  Impact: MEDIUM
Twisted Tongue Inc.
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention Act  ·  Nov 24  ·  Impact: MEDIUM
Ferrum City Liquid
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention Act  ·  Nov 24  ·  Impact: MEDIUM
California Terra Garden Inc.
Foreign supplier verification program non-compliance
Why: Inadequate verification procedures for foreign food suppliers  ·  Nov 10  ·  Impact: MEDIUM
Lempira Distribution LLC
Foreign supplier verification program non-compliance
Why: Inadequate verification of foreign food suppliers  ·  Nov 03  ·  Impact: MEDIUM

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