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MAZZUCCHELLI 1849 SPA

⚠️ Moderate Risk

FEI: 3019664818 • Castiglione • ITALY

FEI

FEI Number

3019664818

📍

Location

Castiglione

🇮🇹

Country

ITALY
🏢

Address

Via S.E.P Mazzucchelli, , Castiglione, , Italy

Moderate Risk

FDA Import Risk Assessment

37.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
11/6/2023
Latest Refusal
11/6/2023
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
11.2×30%
Recency
55.8×20%
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

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
11/6/2023
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
3280FRNMFGREG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is MAZZUCCHELLI 1849 SPA's FDA import refusal history?

MAZZUCCHELLI 1849 SPA (FEI: 3019664818) has 1 FDA import refusal record(s) in our database, spanning from 11/6/2023 to 11/6/2023.

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. MAZZUCCHELLI 1849 SPA's FEI number is 3019664818.

What types of violations has MAZZUCCHELLI 1849 SPA received?

MAZZUCCHELLI 1849 SPA has been cited for 2 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 MAZZUCCHELLI 1849 SPA come from?

All FDA import refusal data for MAZZUCCHELLI 1849 SPA 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.