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Fernando Pensato

⚠️ High Risk

FEI: 3008598320 • Monte Carlo • MONACO

FEI

FEI Number

3008598320

📍

Location

Monte Carlo

🇲🇨

Country

MONACO
🏢

Address

74 Le Monte Bd Dtralie, , Monte Carlo, , Monaco

High Risk

FDA Import Risk Assessment

55.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

4
Total Refusals
1
Unique Violations
11/2/2023
Latest Refusal
11/2/2023
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
25.9×30%
Recency
56.1×20%
Frequency
40.0×10%
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

834×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
11/2/2023
25RCI02TRUFFLE, BROKEN OR KIBBLED
83NO PROCESS
Division of Southeast Imports (DSEI)
11/2/2023
25RCI02TRUFFLE, BROKEN OR KIBBLED
83NO PROCESS
Division of Southeast Imports (DSEI)
11/2/2023
25RCI02TRUFFLE, BROKEN OR KIBBLED
83NO PROCESS
Division of Southeast Imports (DSEI)
11/2/2023
25RCI02TRUFFLE, BROKEN OR KIBBLED
83NO PROCESS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Fernando Pensato's FDA import refusal history?

Fernando Pensato (FEI: 3008598320) has 4 FDA import refusal record(s) in our database, spanning from 11/2/2023 to 11/2/2023.

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. Fernando Pensato's FEI number is 3008598320.

What types of violations has Fernando Pensato received?

Fernando Pensato 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 Fernando Pensato come from?

All FDA import refusal data for Fernando Pensato 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.