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DKS Loversan Industria Biomedica S.p.A.

✅ Low Risk

FEI: 3005376360 • Gemonio, Varese • ITALY

FEI

FEI Number

3005376360

📍

Location

Gemonio, Varese

🇮🇹

Country

ITALY
🏢

Address

Via Giovanni Borghi 24, , Gemonio, Varese, Italy

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
3/23/2017
Latest Refusal
3/23/2017
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

Refusal History

DateProductViolationsDivision
3/23/2017
80FPASET, ADMINISTRATION, INTRAVASCULAR
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is DKS Loversan Industria Biomedica S.p.A.'s FDA import refusal history?

DKS Loversan Industria Biomedica S.p.A. (FEI: 3005376360) has 1 FDA import refusal record(s) in our database, spanning from 3/23/2017 to 3/23/2017.

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. DKS Loversan Industria Biomedica S.p.A.'s FEI number is 3005376360.

What types of violations has DKS Loversan Industria Biomedica S.p.A. received?

DKS Loversan Industria Biomedica S.p.A. 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 DKS Loversan Industria Biomedica S.p.A. come from?

All FDA import refusal data for DKS Loversan Industria Biomedica S.p.A. 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.