Barberini Lenti Specia
⚠️ High Risk
FEI: 3001058669 • Silvi, Teramo • ITALY
FEI
FEI Number
3001058669
📍
Location
Silvi, Teramo
🇮🇹
Country
ITALY🏢
Address
Via Ix Da Denominare 26, , Silvi, Teramo, Italy
High Risk
FDA Import Risk Assessment
53.3
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
124
Total Refusals
2
Unique Violations
7/12/2019
Latest Refusal
12/23/2008
Earliest Refusal
Score Breakdown
Violation Severity
50.0×40%
Refusal Volume
77.7×30%
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
118124×
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).
3280123×
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/12/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Barberini Lenti Specia's FDA import refusal history?
Barberini Lenti Specia (FEI: 3001058669) has 124 FDA import refusal record(s) in our database, spanning from 12/23/2008 to 7/12/2019.
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. Barberini Lenti Specia's FEI number is 3001058669.
What types of violations has Barberini Lenti Specia received?
Barberini Lenti Specia has been cited for 2 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 Barberini Lenti Specia come from?
All FDA import refusal data for Barberini Lenti Specia 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.