Ghetaldus D.O.O.
✅ Low Risk
FEI: 3009956284 • Samobor, Zagrebacka • CROATIA
FEI Number
3009956284
Location
Samobor, Zagrebacka
Country
CROATIAAddress
Rudarska Draga 17, , Samobor, Zagrebacka, Croatia
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/4/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ghetaldus D.O.O.'s FDA import refusal history?
Ghetaldus D.O.O. (FEI: 3009956284) has 1 FDA import refusal record(s) in our database, spanning from 5/4/2015 to 5/4/2015.
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. Ghetaldus D.O.O.'s FEI number is 3009956284.
What types of violations has Ghetaldus D.O.O. received?
Ghetaldus D.O.O. 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 Ghetaldus D.O.O. come from?
All FDA import refusal data for Ghetaldus D.O.O. 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.