Vupiesse Italia Srl
⚠️ Moderate Risk
FEI: 3004629141 • Rimini, Rimini • ITALY
FEI Number
3004629141
Location
Rimini, Rimini
Country
ITALYAddress
49 Via Della Lontra, , Rimini, Rimini, 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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2016 | 84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 8/20/2015 | 84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/27/2015 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 2/2/2015 | 84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Vupiesse Italia Srl's FDA import refusal history?
Vupiesse Italia Srl (FEI: 3004629141) has 4 FDA import refusal record(s) in our database, spanning from 2/2/2015 to 7/26/2016.
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. Vupiesse Italia Srl's FEI number is 3004629141.
What types of violations has Vupiesse Italia Srl received?
Vupiesse Italia Srl 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 Vupiesse Italia Srl come from?
All FDA import refusal data for Vupiesse Italia Srl 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.