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O-Pac

⚠️ Moderate Risk

FEI: 3002459191 • Oggiono, Lecco • ITALY

FEI

FEI Number

3002459191

📍

Location

Oggiono, Lecco

🇮🇹

Country

ITALY
🏢

Address

Via Al Mognago 42, , Oggiono, Lecco, 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
12/21/2015
Latest Refusal
12/21/2015
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

30811×

INVDEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)

Refusal History

DateProductViolationsDivision
12/21/2015
76EFTCLEANSER, DENTURE, OTC
3081INVDEVICE
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is O-Pac's FDA import refusal history?

O-Pac (FEI: 3002459191) has 1 FDA import refusal record(s) in our database, spanning from 12/21/2015 to 12/21/2015.

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. O-Pac's FEI number is 3002459191.

What types of violations has O-Pac received?

O-Pac 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 O-Pac come from?

All FDA import refusal data for O-Pac 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.