ImportRefusal LogoImportRefusal

Olearia Campana S.P.A.

⚠️ Moderate Risk

FEI: 1000617535 • Caserta • ITALY

FEI

FEI Number

1000617535

📍

Location

Caserta

🇮🇹

Country

ITALY
🏢

Address

Trib, S. Maria 246/79, , Caserta, , Italy

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/10/2003
Latest Refusal
7/10/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

832×

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
7/10/2003
16AEE45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
83NO PROCESS
Atlanta District Office (ATL-DO)
7/10/2003
16AEE45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
83NO PROCESS
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Olearia Campana S.P.A.'s FDA import refusal history?

Olearia Campana S.P.A. (FEI: 1000617535) has 2 FDA import refusal record(s) in our database, spanning from 7/10/2003 to 7/10/2003.

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. Olearia Campana S.P.A.'s FEI number is 1000617535.

What types of violations has Olearia Campana S.P.A. received?

Olearia Campana S.P.A. 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 Olearia Campana S.P.A. come from?

All FDA import refusal data for Olearia Campana S.P.A. 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.