Plus Endo
⚠️ Moderate Risk
FEI: 3001262279 • Roi • SWITZERLAND
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
TISSUE
This human cell, tissue, and cellular and tissue-based product is in violation of Section 361 of the Public Health Service Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/22/2004 | 57PH99HUMAN TISSUE, N.E.C. | 478TISSUE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Plus Endo's FDA import refusal history?
Plus Endo (FEI: 3001262279) has 1 FDA import refusal record(s) in our database, spanning from 11/22/2004 to 11/22/2004.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Plus Endo's FEI number is 3001262279.
What types of violations has Plus Endo received?
Plus Endo has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Plus Endo come from?
All FDA import refusal data for Plus Endo is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.