GOLD AND WOOD LUXEMBOURG SA

⚠️ High Risk

FEI: 3027266264 • Troisvierges, Diekirch • LUXEMBOURG

FEI

FEI Number

3027266264

📍

Location

Troisvierges, Diekirch

🇱🇺

Country

LUXEMBOURG

🏢

Address

16 Rue De Drinklange, , Troisvierges, Diekirch, Luxembourg

High Risk

FDA Import Risk Assessment

52.4

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

12/28/2023

Latest Refusal

7/21/2023

Earliest Refusal

Score Breakdown

Violation Severity

51.2×40%

Refusal Volume

37.0×30%

Recency

59.2×20%

Frequency

90.0×10%

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

32808×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

1184×

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).

2354×

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

Date	Product	Violations	Division
12/28/2023	86HQZFRAME, SPECTACLE	235NOT IMPACT 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
11/14/2023	86HQZFRAME, SPECTACLE	235NOT IMPACT 3280FRNMFGREG	Division of Northeast Imports (DNEI)
11/6/2023	86HQZFRAME, SPECTACLE	235NOT IMPACT 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
11/6/2023	86HQZFRAME, SPECTACLE	235NOT IMPACT 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
11/6/2023	86HQZFRAME, SPECTACLE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
11/1/2023	86HQZFRAME, SPECTACLE	118NOT LISTED 3280FRNMFGREG	Division of Northeast Imports (DNEI)
10/10/2023	86HQZFRAME, SPECTACLE	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
9/1/2023	86HQZFRAME, SPECTACLE	341REGISTERED	Division of Northeast Imports (DNEI)
7/21/2023	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 3280FRNMFGREG	Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is GOLD AND WOOD LUXEMBOURG SA's FDA import refusal history?

GOLD AND WOOD LUXEMBOURG SA (FEI: 3027266264) has 9 FDA import refusal record(s) in our database, spanning from 7/21/2023 to 12/28/2023.

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. GOLD AND WOOD LUXEMBOURG SA's FEI number is 3027266264.

What types of violations has GOLD AND WOOD LUXEMBOURG SA received?

GOLD AND WOOD LUXEMBOURG SA has been cited for 4 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 GOLD AND WOOD LUXEMBOURG SA come from?

All FDA import refusal data for GOLD AND WOOD LUXEMBOURG 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.