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Ottica Italfoto

⚠️ Moderate Risk

FEI: 3003273044 • Pisa, Pisa • ITALY

FEI

FEI Number

3003273044

📍

Location

Pisa, Pisa

🇮🇹

Country

ITALY
🏢

Address

Corso Italia 146, , Pisa, Pisa, Italy

Moderate Risk

FDA Import Risk Assessment

28.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/15/2002
Latest Refusal
10/12/2001
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
2/15/2002
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
New Orleans District Office (NOL-DO)
10/12/2001
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ottica Italfoto's FDA import refusal history?

Ottica Italfoto (FEI: 3003273044) has 2 FDA import refusal record(s) in our database, spanning from 10/12/2001 to 2/15/2002.

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. Ottica Italfoto's FEI number is 3003273044.

What types of violations has Ottica Italfoto received?

Ottica Italfoto 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 Ottica Italfoto come from?

All FDA import refusal data for Ottica Italfoto 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.