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Ups Rts 1z597e556794365024

⚠️ Moderate Risk

FEI: 3012329405 • Trevignano Romanotrevignano Romano • ITALY

FEI

FEI Number

3012329405

📍

Location

Trevignano Romanotrevignano Romano

🇮🇹

Country

ITALY
🏢

Address

Gallo, Guendalina Via Garibaldi 61, , Trevignano Romanotrevignano Romano, , Italy

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/23/2016
Latest Refusal
6/23/2016
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1792×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
6/23/2016
80KZHINTRODUCER, SYRINGE NEEDLE
2480RXPERSONAL
Cincinnati District Office (CIN-DO)
6/23/2016
60NCY15TESTOSTERONE CYPIONATE (ANDROGEN)
179AGR RX
Cincinnati District Office (CIN-DO)
6/23/2016
61PDK17INSULIN (INJ) (ANTI-DIABETIC)
179AGR RX
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Ups Rts 1z597e556794365024's FDA import refusal history?

Ups Rts 1z597e556794365024 (FEI: 3012329405) has 3 FDA import refusal record(s) in our database, spanning from 6/23/2016 to 6/23/2016.

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. Ups Rts 1z597e556794365024's FEI number is 3012329405.

What types of violations has Ups Rts 1z597e556794365024 received?

Ups Rts 1z597e556794365024 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 Ups Rts 1z597e556794365024 come from?

All FDA import refusal data for Ups Rts 1z597e556794365024 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.