BENCHMARK ELECTRONICS ROMANIA SR
✅ Low Risk
FEI: 3012477254 • Bucharest, Bucharest • ROMANIA
FEI Number
3012477254
Location
Bucharest, Bucharest
Country
ROMANIAAddress
Strada Herman Oberth NR 2, , Bucharest, Bucharest, Romania
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is BENCHMARK ELECTRONICS ROMANIA SR's FDA import refusal history?
BENCHMARK ELECTRONICS ROMANIA SR (FEI: 3012477254) has 1 FDA import refusal record(s) in our database, spanning from 7/28/2016 to 7/28/2016.
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. BENCHMARK ELECTRONICS ROMANIA SR's FEI number is 3012477254.
What types of violations has BENCHMARK ELECTRONICS ROMANIA SR received?
BENCHMARK ELECTRONICS ROMANIA SR has been cited for 2 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 BENCHMARK ELECTRONICS ROMANIA SR come from?
All FDA import refusal data for BENCHMARK ELECTRONICS ROMANIA SR 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.