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Naja Sa

✅ Low Risk

FEI: 3003335146 • Chaux Du Dombief • FRANCE

FEI

FEI Number

3003335146

📍

Location

Chaux Du Dombief

🇫🇷

Country

FRANCE
🏢

Address

R N 76, , Chaux Du Dombief, , France

Low Risk

FDA Import Risk Assessment

23.7
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
12/6/2011
Latest Refusal
1/10/2007
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.1×10%
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

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

3411×

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

DateProductViolationsDivision
12/6/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
New Orleans District Office (NOL-DO)
1/10/2007
86HQZFRAME, SPECTACLE
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Naja Sa's FDA import refusal history?

Naja Sa (FEI: 3003335146) has 2 FDA import refusal record(s) in our database, spanning from 1/10/2007 to 12/6/2011.

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 Sa's FEI number is 3003335146.

What types of violations has Naja Sa received?

Naja Sa 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 Sa come from?

All FDA import refusal data for Naja Sa 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.