EL. EN. Electronic Engineering SPA
⚠️ Moderate Risk
FEI: 3001431138 • Calenzano, Florence • ITALY
FEI Number
3001431138
Location
Calenzano, Florence
Country
ITALYAddress
Via Baldanzese 17, , Calenzano, Florence, Italy
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2013 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Los Angeles District Office (LOS-DO) | |
| 7/11/2006 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 7/11/2006 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/17/2005 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EL. EN. Electronic Engineering SPA's FDA import refusal history?
EL. EN. Electronic Engineering SPA (FEI: 3001431138) has 4 FDA import refusal record(s) in our database, spanning from 2/17/2005 to 3/21/2013.
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. EL. EN. Electronic Engineering SPA's FEI number is 3001431138.
What types of violations has EL. EN. Electronic Engineering SPA received?
EL. EN. Electronic Engineering SPA 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 EL. EN. Electronic Engineering SPA come from?
All FDA import refusal data for EL. EN. Electronic Engineering SPA 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.