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FDA Enforcement — May 2024 Report

Automated analysis of 14 items from public government data sources. Updated daily.

Summary

14
Total items
11
High impact
3
Medium impact
0
Low impact

High-impact items this period

Fuyang Fuchunjiang Canned Food Co., Ltd.
Low acid canned food regulation violations with adulteration
Why: Inadequate thermal processing or pH control for low acid canned foods  ·  May 31  ·  Impact: HIGH
Rongcheng Jiayuan Food Co., Ltd
Seafood HACCP and CGMP violations causing adulteration
Why: Insanitary conditions and food safety protocol failures in seafood processing  ·  May 31  ·  Impact: HIGH
Konrad Rejdak, M.D., Ph.D.
Bioresearch monitoring IRB protocol violations in clinical research
Why: Institutional review board oversight failures in investigational study conduct  ·  May 29  ·  Impact: HIGH
Art of Beauty Company, Inc.
Unapproved new drug, misbranded, adulterated with CGMP failures
Why: Unauthorized drug claims and manufacturing quality system deficiencies  ·  May 22  ·  Impact: HIGH
SZ Vape LLC, d/b/a Vype Vapor
Tobacco products adulterated and misbranded
Why: Violations of Family Smoking Prevention and Tobacco Control Act  ·  May 13  ·  Impact: HIGH
Golden Shrimp Seafood Joint Stock Company
Seafood manufacturing with insanitary conditions and adulteration
Why: Failure to implement HACCP and maintain sanitary manufacturing conditions  ·  May 13  ·  Impact: HIGH
Aruba Aloe Balm N.V.
CGMP violations in finished pharmaceuticals; adulteration misbranding
Why: Manufacturing practice deficiencies; product contamination or labeling issues  ·  May 13  ·  Impact: HIGH
Biomic Sciences, LLC dba ION Intelligence of Nature
Adulterated finished pharmaceuticals with CGMP violations
Why: Contaminated or substandard pharmaceutical products; manufacturing defects  ·  May 09  ·  Impact: HIGH
Cue Health, Inc.
Adulterated medical devices CGMP QSR violations
Why: Diagnostic device manufacturing quality and design deficiencies  ·  May 09  ·  Impact: HIGH
Natuzen Co., Ltd.
Finished pharmaceutical products adulterated
Why: Current good manufacturing practice violations in pharma production  ·  May 03  ·  Impact: HIGH

Selected medium-impact items

Swity d.o.o.
Acidified food safety violations and emergency permit control
Why: Adulterated and misbranded acidified food products  ·  May 16  ·  Impact: MEDIUM
Genpro Imports & Export Inc.
Foreign supplier verification program compliance failures
Why: Inadequate supplier vetting; import food safety verification gaps  ·  May 14  ·  Impact: MEDIUM
Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia
Adulterated misbranded tobacco vaping products violations
Why: Unapproved tobacco products marketed without proper authorization  ·  May 07  ·  Impact: MEDIUM

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