Grosfilley Lunettes S.A.
✅ Low Risk
FEI: 1000203163 • Oyonnax, AIN • FRANCE
FEI Number
1000203163
Location
Oyonnax, AIN
Country
FRANCEAddress
10 rue Leva, , Oyonnax, AIN, France
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/4/2015 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/4/2015 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/19/2008 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/14/2006 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Grosfilley Lunettes S.A.'s FDA import refusal history?
Grosfilley Lunettes S.A. (FEI: 1000203163) has 4 FDA import refusal record(s) in our database, spanning from 12/14/2006 to 6/4/2015.
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. Grosfilley Lunettes S.A.'s FEI number is 1000203163.
What types of violations has Grosfilley Lunettes S.A. received?
Grosfilley Lunettes S.A. 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 Grosfilley Lunettes S.A. come from?
All FDA import refusal data for Grosfilley Lunettes S.A. 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.