Morla
⚠️ Moderate Risk
FEI: 3011433938 • Besse Antony • FRANCE
FEI Number
3011433938
Location
Besse Antony
Country
FRANCEAddress
15 Georges, , Besse Antony, , 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/11/2015 | 86HNRFORCEPS, OPHTHALMIC | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Morla's FDA import refusal history?
Morla (FEI: 3011433938) has 1 FDA import refusal record(s) in our database, spanning from 5/11/2015 to 5/11/2015.
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. Morla's FEI number is 3011433938.
What types of violations has Morla received?
Morla 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 Morla come from?
All FDA import refusal data for Morla 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.