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Zanotti Pelle Di Zanotti Nives

✅ Low Risk

FEI: 3007880238 • San Mauro Pascoli, Fc • ITALY

FEI

FEI Number

3007880238

📍

Location

San Mauro Pascoli, Fc

🇮🇹

Country

ITALY
🏢

Address

Via San Mauro 65, , San Mauro Pascoli, Fc, 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
7/19/2010
Latest Refusal
7/19/2010
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
7/19/2010
86HQZFRAME, SPECTACLE
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Zanotti Pelle Di Zanotti Nives's FDA import refusal history?

Zanotti Pelle Di Zanotti Nives (FEI: 3007880238) has 1 FDA import refusal record(s) in our database, spanning from 7/19/2010 to 7/19/2010.

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. Zanotti Pelle Di Zanotti Nives's FEI number is 3007880238.

What types of violations has Zanotti Pelle Di Zanotti Nives received?

Zanotti Pelle Di Zanotti Nives 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 Zanotti Pelle Di Zanotti Nives come from?

All FDA import refusal data for Zanotti Pelle Di Zanotti Nives 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.