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FDA Enforcement — May 2023 Report

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

Summary

46
Total items
19
High impact
27
Medium impact
0
Low impact

High-impact items this period

Knobbe Cattle Company Inc.
Illegal drug residue found in animal tissue
Why: Adulterated beef with prohibited drug residues from illegal treatment  ·  May 31  ·  Impact: HIGH
ImprimisRx NJ
Compounding pharmacy - adulterated drug product violation
Why: Improper compounding procedures or contaminated pharmaceutical preparations  ·  May 26  ·  Impact: HIGH
iRhythm Technologies, Inc.
Medical devices non-compliant with Quality System Regulation
Why: Adulterated devices produced under inadequate QSR controls  ·  May 25  ·  Impact: HIGH
citypharma.us
Unlawful sale of unapproved and misbranded drugs online
Why: Distribution of non-FDA approved pharmaceutical products to US consumers via internet  ·  May 22  ·  Impact: HIGH
Carolina Infusion
Compounded drug products adulterated during manufacturing
Why: Failure to maintain adequate compounding pharmacy standards  ·  May 22  ·  Impact: HIGH
Nutra Blend, LLC subsidiary of Land O’Lakes
Medicated animal feed adulterated CGMP violations
Why: Current Good Manufacturing Practice non-compliance in medicated feed production  ·  May 22  ·  Impact: HIGH
I.T.S. GmbH
CGMP and QSR violations in device manufacturing and storage
Why: Inadequate manufacturing controls and storage conditions for devices  ·  May 19  ·  Impact: HIGH
Steiner Biotechnology, LLC
Medical devices non-compliant with CGMP and QSR
Why: Adulterated medical devices from inadequate manufacturing controls  ·  May 19  ·  Impact: HIGH
Champaklal Maganlal Homeo Pharmacy Private Limited
Unapproved new drugs marketed; product misbranding
Why: International company selling unapproved drugs into U.S. market  ·  May 18  ·  Impact: HIGH
Seafood Brothers Inc., DBA G & L Seafood Inc.
HACCP/CGMP violations - adulterated seafood with insanitary conditions
Why: Inadequate sanitation controls and food safety hazard analysis procedures  ·  May 18  ·  Impact: HIGH

Selected medium-impact items

Mobeen Mazhar, M.D.
Investigational device exemption clinical study violations
Why: Non-compliance with IDE protocols and regulatory requirements  ·  May 31  ·  Impact: MEDIUM
Empire Imports, LLC d/b/a Vapor Empire, LLC
Adulterated or misbranded tobacco products violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  May 31  ·  Impact: MEDIUM
The Drip Ship LTD d/b/a buycbdcigarettes
Adulterated or misbranded tobacco products violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  May 31  ·  Impact: MEDIUM
MDM Group Inc. d/b/a Eliquidstop.com
Adulterated or misbranded tobacco products violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  May 31  ·  Impact: MEDIUM
TheSY, LLC d/b/a Element Vape
Adulterated or misbranded tobacco products violation
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  May 31  ·  Impact: MEDIUM

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