Ottica Meloni SAS
⚠️ Moderate Risk
FEI: 3000281423 • Rome, Rome • ITALY
FEI Number
3000281423
Location
Rome, Rome
Country
ITALYAddress
Via Di Tor Pignattara 51/53, , Rome, Rome, Italy
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 4/23/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 86HQZFRAME, SPECTACLE | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 1/13/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Detroit District Office (DET-DO) |
| 1/12/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ottica Meloni SAS's FDA import refusal history?
Ottica Meloni SAS (FEI: 3000281423) has 14 FDA import refusal record(s) in our database, spanning from 1/12/2012 to 1/16/2015.
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. Ottica Meloni SAS's FEI number is 3000281423.
What types of violations has Ottica Meloni SAS received?
Ottica Meloni SAS 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 Ottica Meloni SAS come from?
All FDA import refusal data for Ottica Meloni SAS 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.