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Studio Bertelli

⚠️ Moderate Risk

FEI: 3005631212 • Seravezza, Lucca • ITALY

FEI

FEI Number

3005631212

📍

Location

Seravezza, Lucca

🇮🇹

Country

ITALY
🏢

Address

Via Lorenzo Mancini 103, , Seravezza, Lucca, Italy

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/5/2006
Latest Refusal
4/5/2006
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

1151×

DR QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.

Refusal History

DateProductViolationsDivision
4/5/2006
60LCB05ASPIRIN (ANALGESIC)
115DR QUALITY
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Studio Bertelli's FDA import refusal history?

Studio Bertelli (FEI: 3005631212) has 1 FDA import refusal record(s) in our database, spanning from 4/5/2006 to 4/5/2006.

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. Studio Bertelli's FEI number is 3005631212.

What types of violations has Studio Bertelli received?

Studio Bertelli 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 Studio Bertelli come from?

All FDA import refusal data for Studio Bertelli 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.