MANUFACTURE KERING EYEWEAR
⚠️ Moderate Risk
FEI: 3016567262 • Sucy En Brie, Val de Marne • FRANCE
FEI Number
3016567262
Location
Sucy En Brie, Val de Marne
Country
FRANCEAddress
1 Rue Benjamin Franklin, , Sucy En Brie, Val de Marne, 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
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 |
|---|---|---|---|
| 2/2/2024 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is MANUFACTURE KERING EYEWEAR's FDA import refusal history?
MANUFACTURE KERING EYEWEAR (FEI: 3016567262) has 1 FDA import refusal record(s) in our database, spanning from 2/2/2024 to 2/2/2024.
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. MANUFACTURE KERING EYEWEAR's FEI number is 3016567262.
What types of violations has MANUFACTURE KERING EYEWEAR received?
MANUFACTURE KERING EYEWEAR has been cited for 1 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 MANUFACTURE KERING EYEWEAR come from?
All FDA import refusal data for MANUFACTURE KERING EYEWEAR 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.