Go Eyewear
⚠️ Moderate Risk
FEI: 3008741522 • Lisbon, Lisboa • PORTUGAL
FEI Number
3008741522
Location
Lisbon, Lisboa
Country
PORTUGALAddress
Loja 2, Avenida Amelia 76RODRIGUES LT, Lisbon, Lisboa, Portugal
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
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).
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).
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 |
|---|---|---|---|
| 12/12/2011 | 86HQZFRAME, SPECTACLE | New Orleans District Office (NOL-DO) | |
| 12/12/2011 | 86HQZFRAME, SPECTACLE | New Orleans District Office (NOL-DO) | |
| 12/12/2011 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Go Eyewear's FDA import refusal history?
Go Eyewear (FEI: 3008741522) has 3 FDA import refusal record(s) in our database, spanning from 12/12/2011 to 12/12/2011.
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. Go Eyewear's FEI number is 3008741522.
What types of violations has Go Eyewear received?
Go Eyewear 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 Go Eyewear come from?
All FDA import refusal data for Go Eyewear 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.