Our Mission
The U.S. food, drug, and medical device markets are vast, and regulatory enforcement resources are limited. Companies operating outside FDA compliance — through misbranding, adulteration, unapproved drug marketing, and cGMP violations — put public health at risk.
FDAOffenders.com exists to bridge this gap. We accept community submissions of evidence against companies suspected of FDA regulatory violations, independently verify claims against public records and enforcement databases, and publish detailed compliance reports that anyone can access for free.
Investigation Methodology
Every report published on FDAOffenders.com undergoes a multi-stage verification process:
- Community Intake: Reports begin with evidence submitted by consumers, industry professionals, or regulatory observers
- FDA Database Cross-Reference: We search FDA Warning Letters, 483 Observations, Enforcement Reports, Import Alerts, and establishment registrations
- Corporate Records Check: We verify LLC/corporation filings through Secretary of State databases, checking formation dates and registered agents
- Product & Label Analysis: Claims on labels, websites, and marketing materials are reviewed against FDA regulations
- cGMP Compliance Assessment: Manufacturing claims are evaluated against 21 CFR Part 211 and related regulations
- Digital Forensics: Domain registration dates, platform compliance checks, and historical web archive analysis
- Enforcement History: Prior warning letters, consent decrees, seizures, injunctions, and criminal actions are documented
Compliance Status System
Each investigated company receives a compliance status based on the weight of evidence gathered:
Violation Confirmed
Verified FDA violations with documented enforcement actions, warning letters, or confirmed regulatory breaches.
Non-Compliant
Significant compliance gaps identified but no formal FDA enforcement action documented at this time.
Under Review
Evidence submitted and under investigation. Verification in progress against FDA databases and public records.
Compliant
Previously investigated company that has corrected violations and demonstrated regulatory compliance.
Databases We Check
✓ FDA Warning Letters
✓ FDA 483 Observations
✓ FDA Enforcement Reports
✓ FDA Import Alerts
✓ FDA 503B Registry
✓ State SOS Filings
✓ DEA Registrations
✓ EPA Records
✓ OSHA Citations
✓ USPTO Trademarks
✓ BBB Listings
✓ Web Archive
Get Involved
FDAOffenders.com is only as strong as the community behind it. If you have knowledge of an FDA regulatory violation, submit a report with whatever evidence you have. Every submission — from a single document to a full compliance dossier — helps protect public health.
Companies that believe they have been unfairly characterized may also submit evidence through the same form. We publish corrections and updates transparently.