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FDA Enforcement — November 2024 Report

Automated analysis of 37 items from public government data sources. Updated daily.

Summary

37
Total items
25
High impact
12
Medium impact
0
Low impact

High-impact items this period

Duong Ha Processing Trading Seafood Company Limited
Seafood HACCP and adulteration violation
Why: Seafood processing failed hazard analysis critical control points  ·  Nov 26  ·  Impact: HIGH
Becton, Dickinson, and Company/CareFusion 303, Inc.
Medical device CGMP and QSR violations with adulteration
Why: Quality system failures in device manufacturing and labeling  ·  Nov 22  ·  Impact: HIGH
Mid America Pet Food LLC
Animal food produced under insanitary CGMP conditions
Why: Inadequate sanitation and contamination controls in manufacturing  ·  Nov 22  ·  Impact: HIGH
Dr. Brite, LLC
CGMP violations in finished pharmaceuticals manufacturing
Why: Adulterated products from inadequate quality control systems  ·  Nov 21  ·  Impact: HIGH
LCC Ltd.
Adulterated unapproved misbranded pharmaceutical violations
Why: CGMP failures, unapproved new drugs, and misbranding in pharmaceuticals  ·  Nov 21  ·  Impact: HIGH
Catwalk Cosmetic Laboratories Pty Ltd.
Adulterated finished pharmaceuticals CGMP violations
Why: Current good manufacturing practice non-compliance in pharmaceutical production  ·  Nov 21  ·  Impact: HIGH
Eurosirel S.P.A
Adulterated finished pharmaceuticals CGMP violations
Why: Current good manufacturing practice non-compliance in pharmaceutical production  ·  Nov 20  ·  Impact: HIGH
Hangzhou Huiji Biotechnology Co., Ltd.
Adulterated finished pharmaceuticals CGMP violations
Why: Current good manufacturing practice non-compliance in pharmaceutical production  ·  Nov 18  ·  Impact: HIGH
Breadbox Co.
Seafood HACCP adulteration and insanitary conditions
Why: Failure to implement seafood safety protocols and maintain sanitary conditions  ·  Nov 18  ·  Impact: HIGH
Centura Pharmaceuticals Inc
Unapproved drug; misbranded OTC pharmaceutical product
Why: Marketing unapproved drug or misrepresenting OTC drug status  ·  Nov 15  ·  Impact: HIGH

Selected medium-impact items

Stew Leonard’s Holdings LLC
Misbranded food labeling violations
Why: Non-compliant food product labeling and consumer disclosure requirements  ·  Nov 18  ·  Impact: MEDIUM
Western Innovations, Inc.
Dietary supplement CGMP adulteration violation
Why: Supplement manufacturing failed current good manufacturing practices  ·  Nov 13  ·  Impact: MEDIUM
Nutrition Strength Ltd.
Animal drug product adulterated; unapproved new animal drug
Why: Violation of animal drug approval requirements and CGMP standards  ·  Nov 12  ·  Impact: MEDIUM
HDFrenchies LLC dba Bully Baum
New animal drug adulterated violation
Why: Pet product failed to meet FDA safety or quality standards  ·  Nov 12  ·  Impact: MEDIUM
Veterinary Select Formula dba Allergic Pet
Animal drug product adulterated; unapproved new animal drug
Why: Violation of animal drug approval requirements and CGMP standards  ·  Nov 12  ·  Impact: MEDIUM

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