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FDA Enforcement — September 2024 Report

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

Summary

32
Total items
17
High impact
15
Medium impact
0
Low impact

High-impact items this period

Dalai Biotech Company Ltd
Low acid canned food regulation adulteration violations
Why: Non-compliance with low-acid canned food processing and safety requirements  ·  Sep 30  ·  Impact: HIGH
Knickerbocker 365 Inc.
Human food manufacturing with insanitary conditions and adulteration
Why: CGMP violations including inadequate sanitation controls  ·  Sep 30  ·  Impact: HIGH
Mexicanrxpharm.com
Unlawful sale of unapproved drugs over internet
Why: Marketing and distributing unapproved pharmaceuticals to US consumers  ·  Sep 30  ·  Impact: HIGH
Bacalao Giraldo, S.L.U.
Seafood adulterated HACCP and CGMP violations
Why: Failure to implement Seafood HACCP and food manufacturing standards  ·  Sep 30  ·  Impact: HIGH
Louisiana State University Health Science Center IRB
Institutional Review Board compliance violations
Why: IRB failures in oversight of clinical research studies  ·  Sep 27  ·  Impact: HIGH
Bernardo Farms, LLC
Produce grown under insanitary conditions adulterated
Why: Non-compliance with produce safety standards and insanitary practices  ·  Sep 25  ·  Impact: HIGH
Outin Futures Corp.
Adulterated and misbranded finished pharmaceutical products
Why: CGMP violations in pharmaceutical manufacturing and labeling  ·  Sep 25  ·  Impact: HIGH
Azurity Pharmaceuticals, Inc.
Adulterated unapproved new drug finished pharmaceuticals
Why: CGMP violations combined with unauthorized drug product manufacturing  ·  Sep 20  ·  Impact: HIGH
Breeze Smoke Official
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Sep 12  ·  Impact: HIGH
Nomida.biz
Unapproved new drugs and misbranded products
Why: Distribution of unapproved pharmaceutical products without proper labeling  ·  Sep 12  ·  Impact: HIGH

Selected medium-impact items

Consolidated Trading, Inc., d/b/a Blue Ox Vapor
Tobacco products adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Sep 30  ·  Impact: MEDIUM
Miyajima Shoyu Co., Ltd.
Acidified food emergency permit control violation
Why: Acidified product failed emergency permit requirements  ·  Sep 30  ·  Impact: MEDIUM
Southeast Distro Inc.
Tobacco products adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Sep 25  ·  Impact: MEDIUM
MR FOG d/b/a MR FOG Officials
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Sep 12  ·  Impact: MEDIUM
FUNCOOL Technology Co., Limited d/b/a RAZ Vape
Tobacco product adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Sep 12  ·  Impact: MEDIUM

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