Trevi-Coliseum SRL
⚠️ Moderate Risk
FEI: 3002558390 • Longarone, Belluno • ITALY
FEI Number
3002558390
Location
Longarone, Belluno
Country
ITALYAddress
Zona Industriale, , Longarone, Belluno, 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.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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 |
|---|---|---|---|
| 1/26/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 1/24/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New York District Office (NYK-DO) | |
| 10/25/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 10/25/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 10/25/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 10/25/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 10/25/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 10/25/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 10/25/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 10/25/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 10/18/2003 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 3/14/2003 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Trevi-Coliseum SRL's FDA import refusal history?
Trevi-Coliseum SRL (FEI: 3002558390) has 12 FDA import refusal record(s) in our database, spanning from 3/14/2003 to 1/26/2016.
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. Trevi-Coliseum SRL's FEI number is 3002558390.
What types of violations has Trevi-Coliseum SRL received?
Trevi-Coliseum SRL 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 Trevi-Coliseum SRL come from?
All FDA import refusal data for Trevi-Coliseum SRL 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.