Gold & Wood
⚠️ Moderate Risk
FEI: 3003185152 • Hosingen • LUXEMBOURG
FEI Number
3003185152
Location
Hosingen
Country
LUXEMBOURGAddress
6a Opderhei, , Hosingen, , Luxembourg
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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 |
|---|---|---|---|
| 2/23/2005 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
| 2/23/2005 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Cincinnati District Office (CIN-DO) | |
| 10/26/2004 | 86HPAFRAME, TRIAL, OPHTHALMIC | 341REGISTERED | New York District Office (NYK-DO) |
| 10/26/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | New York District Office (NYK-DO) |
| 10/26/2004 | 86HPAFRAME, TRIAL, OPHTHALMIC | 341REGISTERED | New York District Office (NYK-DO) |
| 10/26/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | New York District Office (NYK-DO) |
| 10/26/2004 | 86HPAFRAME, TRIAL, OPHTHALMIC | 341REGISTERED | New York District Office (NYK-DO) |
| 10/26/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | New York District Office (NYK-DO) |
| 10/26/2004 | 86HPAFRAME, TRIAL, OPHTHALMIC | 341REGISTERED | New York District Office (NYK-DO) |
| 10/26/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Gold & Wood's FDA import refusal history?
Gold & Wood (FEI: 3003185152) has 10 FDA import refusal record(s) in our database, spanning from 10/26/2004 to 2/23/2005.
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 & Wood's FEI number is 3003185152.
What types of violations has Gold & Wood received?
Gold & Wood 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 Gold & Wood come from?
All FDA import refusal data for Gold & Wood 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.