Institute Venezalano
⚠️ Moderate Risk
FEI: 3005921221 • Amess • VENEZUELA
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/12/2006 | 60RBY18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC) | New Orleans District Office (NOL-DO) | |
| 10/12/2006 | 65MBY99PROTHYROTROPIN N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/12/2006 | 66FBY05COLCHICINE (SUPPRESSANT) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Institute Venezalano's FDA import refusal history?
Institute Venezalano (FEI: 3005921221) has 3 FDA import refusal record(s) in our database, spanning from 10/12/2006 to 10/12/2006.
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. Institute Venezalano's FEI number is 3005921221.
What types of violations has Institute Venezalano received?
Institute Venezalano has been cited for 4 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 Institute Venezalano come from?
All FDA import refusal data for Institute Venezalano 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.