Victor Otero
⚠️ Moderate Risk
FEI: 3005320822 • Santiago • DOMINICAN REPUBLIC
FEI Number
3005320822
Location
Santiago
Country
DOMINICAN REPUBLICAddress
C/A Res Carla I, , Santiago, , Dominican Republic
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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is Victor Otero's FDA import refusal history?
Victor Otero (FEI: 3005320822) has 2 FDA import refusal record(s) in our database, spanning from 10/24/2005 to 10/24/2005.
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. Victor Otero's FEI number is 3005320822.
What types of violations has Victor Otero received?
Victor Otero 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 Victor Otero come from?
All FDA import refusal data for Victor Otero 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.