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I.C.E. (Industria Chimica Emiliana) Srl

✅ Low Risk

FEI: 3000133419 • Reggio Emilia, Reggio Emilia • ITALY

FEI

FEI Number

3000133419

📍

Location

Reggio Emilia, Reggio Emilia

🇮🇹

Country

ITALY
🏢

Address

Via Sicilia 8/10, , Reggio Emilia, Reggio Emilia, 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
5/3/2011
Latest Refusal
5/3/2011
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
5/3/2011
63MAR02DEHYDROCHOLIC ACID (CHOLERETIC)
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is I.C.E. (Industria Chimica Emiliana) Srl's FDA import refusal history?

I.C.E. (Industria Chimica Emiliana) Srl (FEI: 3000133419) has 1 FDA import refusal record(s) in our database, spanning from 5/3/2011 to 5/3/2011.

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. I.C.E. (Industria Chimica Emiliana) Srl's FEI number is 3000133419.

What types of violations has I.C.E. (Industria Chimica Emiliana) Srl received?

I.C.E. (Industria Chimica Emiliana) Srl 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 I.C.E. (Industria Chimica Emiliana) Srl come from?

All FDA import refusal data for I.C.E. (Industria Chimica Emiliana) 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.