Luxottica Spa
⚠️ High Risk
FEI: 3010323892 • Milan, Milan • ITALY
FEI
FEI Number
3010323892
📍
Location
Milan, Milan
🇮🇹
Country
ITALY🏢
Address
Via Cesare Cantu' 2/20213, , Milan, Milan, Italy
High Risk
FDA Import Risk Assessment
55.5
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
200
Total Refusals
3
Unique Violations
4/5/2018
Latest Refusal
11/2/2017
Earliest Refusal
Score Breakdown
Violation Severity
49.8×40%
Refusal Volume
85.3×30%
Recency
0.0×20%
Frequency
100.0×10%
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
© ImportRefusal.com Original Analysis
Violation Summary
118200×
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).
328088×
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.
3413×
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 |
|---|---|---|---|
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/5/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/1/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/23/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/12/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/12/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/8/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/8/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/8/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/8/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 1/8/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/8/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/8/2018 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | Division of Northern Border Imports (DNBI) | |
| 1/8/2018 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | Division of Northern Border Imports (DNBI) | |
| 1/4/2018 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/3/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/3/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/3/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/3/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/3/2018 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/3/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Luxottica Spa's FDA import refusal history?
Luxottica Spa (FEI: 3010323892) has 200 FDA import refusal record(s) in our database, spanning from 11/2/2017 to 4/5/2018.
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. Luxottica Spa's FEI number is 3010323892.
What types of violations has Luxottica Spa received?
Luxottica Spa 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 Luxottica Spa come from?
All FDA import refusal data for Luxottica Spa 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.