ImportRefusal LogoImportRefusal

FENNOBON OY

⚠️ Moderate Risk

FEI: 3004393748 • Karkkila, Helsinki-Uusimaa • FINLAND

FEI

FEI Number

3004393748

📍

Location

Karkkila, Helsinki-Uusimaa

🇫🇮

Country

FINLAND
🏢

Address

Yrittajantie 28, , Karkkila, Helsinki-Uusimaa, Finland

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/9/2004
Latest Refusal
1/13/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

1181×

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).

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

Refusal History

DateProductViolationsDivision
7/9/2004
33UDY02CHEWING GUM (WITHOUT CHOCOLATE)
118NOT LISTED
New Orleans District Office (NOL-DO)
1/13/2004
33UYY02CHEWING GUM (WITHOUT CHOCOLATE)
238UNSAFE ADD
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is FENNOBON OY's FDA import refusal history?

FENNOBON OY (FEI: 3004393748) has 2 FDA import refusal record(s) in our database, spanning from 1/13/2004 to 7/9/2004.

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. FENNOBON OY's FEI number is 3004393748.

What types of violations has FENNOBON OY received?

FENNOBON OY 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 FENNOBON OY come from?

All FDA import refusal data for FENNOBON OY 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.