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FDA Enforcement — June 2025 Report

Automated analysis of 36 items from public government data sources. Updated daily.

Summary

36
Total items
24
High impact
12
Medium impact
0
Low impact

High-impact items this period

Mectronic Medicale S.R.L.
Medical devices manufactured without CGMP/QSR compliance
Why: Failure to implement current good manufacturing practices for device production  ·  Jun 27  ·  Impact: HIGH
Libby Laboratories, Inc.
CGMP violations in finished pharmaceutical manufacturing
Why: Failure to maintain Current Good Manufacturing Practice standards  ·  Jun 27  ·  Impact: HIGH
Xtreme Tools International, Inc.
CGMP violations in finished pharmaceutical manufacturing
Why: Failure to maintain Current Good Manufacturing Practice standards  ·  Jun 25  ·  Impact: HIGH
Performance Plus Marketing Inc.
Tobacco products adulterated, misbranded, unapproved
Why: Violation of Tobacco Control Act sales and labeling requirements  ·  Jun 18  ·  Impact: HIGH
Dynamic Blending Specialists, Inc.
CGMP violations in finished pharmaceutical manufacturing
Why: Failure to maintain Current Good Manufacturing Practice standards  ·  Jun 18  ·  Impact: HIGH
Peter Michael, M.D.
Clinical investigator compliance violations
Why: Failure to comply with clinical trial investigator regulatory requirements  ·  Jun 18  ·  Impact: HIGH
Lystn LLC dba Answers Pet Food
Animal feed prepared under insanitary conditions
Why: CGMP violations and insanitary handling of pet food products  ·  Jun 18  ·  Impact: HIGH
Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi
Finished pharmaceutical CGMP violations; adulterated products
Why: Manufacturing quality system deficiencies in pharmaceutical production  ·  Jun 16  ·  Impact: HIGH
www.soma4ever.com
Unlawful internet sale of unapproved, misbranded drugs
Why: Online distribution of controlled substances without authorization  ·  Jun 13  ·  Impact: HIGH
Visgeneer, Inc
Medical devices adulterated or misbranded CGMP/QSR violations
Why: Failure to meet Current Good Manufacturing Practice and Quality System Regulation standards  ·  Jun 13  ·  Impact: HIGH

Selected medium-impact items

bestvape.com
Tobacco control act violation with adulterated and misbranded products
Why: Non-compliance with tobacco product regulations and labeling requirements  ·  Jun 27  ·  Impact: MEDIUM
puff21.com
Tobacco products adulterated and misbranded
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Jun 27  ·  Impact: MEDIUM
Nepa Wholesale Inc.
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Jun 26  ·  Impact: MEDIUM
Kure CBD & Vape
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Jun 26  ·  Impact: MEDIUM
GPO Plus Inc, d/b/a Distro+
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act  ·  Jun 26  ·  Impact: MEDIUM

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