Henri Laboratorios
⚠️ Moderate Risk
FEI: 3006986062 • Bogota • COLOMBIA
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
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/30/2008 | 61HCJ99ANTI-BACTERIAL, N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Henri Laboratorios's FDA import refusal history?
Henri Laboratorios (FEI: 3006986062) has 1 FDA import refusal record(s) in our database, spanning from 7/30/2008 to 7/30/2008.
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. Henri Laboratorios's FEI number is 3006986062.
What types of violations has Henri Laboratorios received?
Henri Laboratorios 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 Henri Laboratorios come from?
All FDA import refusal data for Henri Laboratorios 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.