Bli/Dbp
⚠️ Moderate Risk
FEI: 3004499237 • Marseille, Bouches Du Rhone • FRANCE
FEI Number
3004499237
Location
Marseille, Bouches Du Rhone
Country
FRANCEAddress
Ch De St Menet Aux Accates, , Marseille, Bouches Du Rhone, France
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 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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Northern Border Imports (DNBI) |
| 8/4/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 10/16/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Northern Border Imports (DNBI) |
| 5/6/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New York District Office (NYK-DO) |
| 5/6/2015 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New York District Office (NYK-DO) |
| 5/6/2015 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bli/Dbp's FDA import refusal history?
Bli/Dbp (FEI: 3004499237) has 6 FDA import refusal record(s) in our database, spanning from 5/6/2015 to 9/26/2016.
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. Bli/Dbp's FEI number is 3004499237.
What types of violations has Bli/Dbp received?
Bli/Dbp 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 Bli/Dbp come from?
All FDA import refusal data for Bli/Dbp 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.