De Rigo Vision S.p.A.

⚠️ Moderate Risk

FEI: 3005246919 • Longarone, Belluno • ITALY

FEI

FEI Number

3005246919

📍

Location

Longarone, Belluno

🇮🇹

Country

ITALY

🏢

Address

Zona Industriale Villanova 12, , Longarone, Belluno, Italy

Moderate Risk

FDA Import Risk Assessment

30.1

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/5/2017

Latest Refusal

11/19/2010

Earliest Refusal

Score Breakdown

Violation Severity

33.9×40%

Refusal Volume

46.5×30%

Recency

0.0×20%

Frequency

26.0×10%

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

Violation Summary

34116×

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).

1181×

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).

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

Date	Product	Violations	Division
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
6/5/2017	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
11/19/2010	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 126FAILS STD	Florida District Office (FLA-DO)

Frequently Asked Questions

What is De Rigo Vision S.p.A.'s FDA import refusal history?

De Rigo Vision S.p.A. (FEI: 3005246919) has 17 FDA import refusal record(s) in our database, spanning from 11/19/2010 to 6/5/2017.

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. De Rigo Vision S.p.A.'s FEI number is 3005246919.

What types of violations has De Rigo Vision S.p.A. received?

De Rigo Vision S.p.A. has been cited for 3 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 De Rigo Vision S.p.A. come from?

All FDA import refusal data for De Rigo Vision S.p.A. 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.