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FDA Enforcement — September 2025 Report

Automated analysis of 74 items from public government data sources. Updated daily.

Summary

74
Total items
50
High impact
24
Medium impact
0
Low impact

High-impact items this period

Allovate Therapeutics, LLC
CGMP deviations in biologics license application manufacturing
Why: Failure to maintain current Good Manufacturing Practice standards in BLA production  ·  Sep 30  ·  Impact: HIGH
Guangxi Yulin Pharmaceutical Group Co. Ltd.
CGMP violations in adulterated finished pharmaceutical production
Why: Manufacturing process deviations compromising product purity and safety  ·  Sep 30  ·  Impact: HIGH
Technological Medical Advancements LLC
Medical device CGMP and quality system violations
Why: Non-compliance with current Good Manufacturing Practice requirements  ·  Sep 26  ·  Impact: HIGH
Naturich Cosmetique Labs
Finished pharmaceutical products adulterated under CGMP
Why: Failure to maintain current Good Manufacturing Practice standards  ·  Sep 25  ·  Impact: HIGH
Creative Essences, Inc.
Finished pharmaceutical products adulterated under CGMP
Why: Failure to maintain current Good Manufacturing Practice standards  ·  Sep 25  ·  Impact: HIGH
New Life Medical Services, LLC
CGMP deviations in biologic license application operations
Why: Failure to maintain current Good Manufacturing Practice standards  ·  Sep 24  ·  Impact: HIGH
Las Americas Supermercado#2 Inc.
Failed Foreign Supplier Verification Program compliance
Why: Inadequate verification procedures for imported food suppliers  ·  Sep 24  ·  Impact: HIGH
Adja Khady Food Distribution Inc
Foreign Supplier Verification Program non-compliance
Why: Inadequate verification procedures for imported food suppliers  ·  Sep 24  ·  Impact: HIGH
Persōn & Covey, Inc.
Current good manufacturing practice violations in pharmaceutical production
Why: Deficient manufacturing controls, quality assurance, or product adulteration  ·  Sep 23  ·  Impact: HIGH
Revive Rx LLC dba Revive Rx Pharmacy
Compounding pharmacy producing adulterated drug products
Why: Compounded pharmaceutical products adulterated or improperly manufactured  ·  Sep 22  ·  Impact: HIGH

Selected medium-impact items

sinzs.net
Online tobacco sales non-compliant with FSPTCA requirements
Why: Illicit or improperly regulated tobacco product online distribution  ·  Sep 26  ·  Impact: MEDIUM
discountvapeoutlet.com
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Sep 26  ·  Impact: MEDIUM
AK WHOLESALE INC.
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Sep 25  ·  Impact: MEDIUM
Nimbus Imports Inc, d/b/a Nimbus Wholesale
Tobacco product adulteration and misbranding violations
Why: Failure to comply with Family Smoking Prevention Act requirements  ·  Sep 25  ·  Impact: MEDIUM
Elite Vapor LLC
Tobacco product adulteration and misbranding violations
Why: Non-compliance with Family Smoking Prevention and Tobacco Control Act requirements  ·  Sep 25  ·  Impact: MEDIUM

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