Lunettes Rege & Associates Sa
⚠️ Moderate Risk
FEI: 3007131440 • Cedex • FRANCE
FEI Number
3007131440
Location
Cedex
Country
FRANCEAddress
Za En Borreymartignat, , Cedex, , 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 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).
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 |
|---|---|---|---|
| 5/5/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New York District Office (NYK-DO) | |
| 5/5/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Lunettes Rege & Associates Sa's FDA import refusal history?
Lunettes Rege & Associates Sa (FEI: 3007131440) has 2 FDA import refusal record(s) in our database, spanning from 5/5/2015 to 5/5/2015.
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. Lunettes Rege & Associates Sa's FEI number is 3007131440.
What types of violations has Lunettes Rege & Associates Sa received?
Lunettes Rege & Associates Sa 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 Lunettes Rege & Associates Sa come from?
All FDA import refusal data for Lunettes Rege & Associates Sa 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.