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Silhouette International Schmied Ag

✅ Low Risk

FEI: 3008345156 • Linz, Oberosterreich • AUSTRIA

FEI

FEI Number

3008345156

📍

Location

Linz, Oberosterreich

🇦🇹

Country

AUSTRIA
🏢

Address

Ellbognerstrase 24, , Linz, Oberosterreich, Austria

Low Risk

FDA Import Risk Assessment

24.1
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
5/1/2019
Latest Refusal
7/26/2013
Earliest Refusal

Score Breakdown

Violation Severity
34.3×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
10.4×10%
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

3416×

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).

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
5/1/2019
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Division of Southeast Imports (DSEI)
4/26/2018
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southeast Imports (DSEI)
11/22/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Florida District Office (FLA-DO)
11/22/2013
86HQZFRAME, SPECTACLE
341REGISTERED
Florida District Office (FLA-DO)
8/30/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southeast Imports (DSEI)
7/26/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Silhouette International Schmied Ag's FDA import refusal history?

Silhouette International Schmied Ag (FEI: 3008345156) has 6 FDA import refusal record(s) in our database, spanning from 7/26/2013 to 5/1/2019.

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. Silhouette International Schmied Ag's FEI number is 3008345156.

What types of violations has Silhouette International Schmied Ag received?

Silhouette International Schmied Ag 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 Silhouette International Schmied Ag come from?

All FDA import refusal data for Silhouette International Schmied Ag 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.