Sistema Sviluppo Servizi Srl
⚠️ Moderate Risk
FEI: 3002733826 • Verona • 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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2003 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | New Orleans District Office (NOL-DO) | |
| 12/3/2003 | 57DY24PLASMA PROTEIN FRACTION (HUMAN) (BLOOD AND BLOOD DERIVATIVES) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sistema Sviluppo Servizi Srl's FDA import refusal history?
Sistema Sviluppo Servizi Srl (FEI: 3002733826) has 3 FDA import refusal record(s) in our database, spanning from 12/3/2003 to 12/5/2003.
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. Sistema Sviluppo Servizi Srl's FEI number is 3002733826.
What types of violations has Sistema Sviluppo Servizi Srl received?
Sistema Sviluppo Servizi 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 Sistema Sviluppo Servizi Srl come from?
All FDA import refusal data for Sistema Sviluppo Servizi 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.