Ortoiberica S.L.
✅ Low Risk
FEI: 3009638795 • Principado De Asturias • SPAIN
FEI Number
3009638795
Location
Principado De Asturias
Country
SPAINAddress
Parque Tecnologico De Asturias, , Principado De Asturias, , Spain
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/7/2012 | 80FMPPROTECTOR, SKIN PRESSURE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ortoiberica S.L.'s FDA import refusal history?
Ortoiberica S.L. (FEI: 3009638795) has 1 FDA import refusal record(s) in our database, spanning from 8/7/2012 to 8/7/2012.
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. Ortoiberica S.L.'s FEI number is 3009638795.
What types of violations has Ortoiberica S.L. received?
Ortoiberica S.L. 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 Ortoiberica S.L. come from?
All FDA import refusal data for Ortoiberica S.L. 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.