U.S. Naval Hospital Rota (Mammography)
✅ Low Risk
FEI: 3002809170 • Rota • SPAIN
FEI Number
3002809170
Location
Rota
Country
SPAINAddress
Psc 819, Box 18, Fpo Ae 049, , Rota, , 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 |
|---|---|---|---|
| 7/25/2005 | 77EWOAUDIOMETER | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is U.S. Naval Hospital Rota (Mammography)'s FDA import refusal history?
U.S. Naval Hospital Rota (Mammography) (FEI: 3002809170) has 1 FDA import refusal record(s) in our database, spanning from 7/25/2005 to 7/25/2005.
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. U.S. Naval Hospital Rota (Mammography)'s FEI number is 3002809170.
What types of violations has U.S. Naval Hospital Rota (Mammography) received?
U.S. Naval Hospital Rota (Mammography) 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 U.S. Naval Hospital Rota (Mammography) come from?
All FDA import refusal data for U.S. Naval Hospital Rota (Mammography) 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.