Naja Sas
✅ Low Risk
FEI: 3005753764 • Chaux du Dombief, Jura • FRANCE
FEI Number
3005753764
Location
Chaux du Dombief, Jura
Country
FRANCEAddress
Entree 6, 8 P Zila Halle, Chaux du Dombief, Jura, France
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).
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 |
|---|---|---|---|
| 6/26/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/19/2008 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 10/15/2007 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New York District Office (NYK-DO) |
| 10/2/2007 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Naja Sas's FDA import refusal history?
Naja Sas (FEI: 3005753764) has 4 FDA import refusal record(s) in our database, spanning from 10/2/2007 to 6/26/2015.
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. Naja Sas's FEI number is 3005753764.
What types of violations has Naja Sas received?
Naja Sas 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 Naja Sas come from?
All FDA import refusal data for Naja Sas 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.