Amikli
⚠️ Moderate Risk
FEI: 3003652043 • Massy, Essonne • FRANCE
FEI Number
3003652043
Location
Massy, Essonne
Country
FRANCEAddress
4 Rue Galvani, , Massy, Essonne, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/5/2004 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 5/5/2004 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/5/2004 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Amikli's FDA import refusal history?
Amikli (FEI: 3003652043) has 3 FDA import refusal record(s) in our database, spanning from 5/5/2004 to 5/5/2004.
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. Amikli's FEI number is 3003652043.
What types of violations has Amikli received?
Amikli 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 Amikli come from?
All FDA import refusal data for Amikli 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.