FIAB spa
⚠️ Moderate Risk
FEI: 3003072803 • Vicchio, Florence • ITALY
FEI Number
3003072803
Location
Vicchio, Florence
Country
ITALYAddress
Via Bruno Passerini 2, , Vicchio, 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
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).
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).
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.
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/2/2018 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/12/2015 | 74LDDDC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 1/3/2014 | 84GXYELECTRODE, CUTANEOUS | New Orleans District Office (NOL-DO) | |
| 12/11/2013 | 79DWGELECTROSURGICAL DEVICE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 3/12/2008 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | New Orleans District Office (NOL-DO) | |
| 5/12/2005 | 74MLNELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is FIAB spa's FDA import refusal history?
FIAB spa (FEI: 3003072803) has 6 FDA import refusal record(s) in our database, spanning from 5/12/2005 to 11/2/2018.
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. FIAB spa's FEI number is 3003072803.
What types of violations has FIAB spa received?
FIAB spa has been cited for 7 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 FIAB spa come from?
All FDA import refusal data for FIAB 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.