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BISCOTTI SA

⚠️ Moderate Risk

FEI: 3011854964 • Thessaloniki • GREECE

FEI

FEI Number

3011854964

📍

Location

Thessaloniki

🇬🇷

Country

GREECE
🏢

Address

Interbalkan Area, , Thessaloniki, , Greece

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/4/2015
Latest Refusal
12/4/2015
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

33001×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

Refusal History

DateProductViolationsDivision
12/4/2015
03NFO03PASTRY (ECLAIRS, CREAM PUFFS) CUSTARD OR CREAM FILLED
218LIST INGRE
3300ALLERGEN
New England District Office (NWE-DO)

Frequently Asked Questions

What is BISCOTTI SA's FDA import refusal history?

BISCOTTI SA (FEI: 3011854964) has 1 FDA import refusal record(s) in our database, spanning from 12/4/2015 to 12/4/2015.

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. BISCOTTI SA's FEI number is 3011854964.

What types of violations has BISCOTTI SA received?

BISCOTTI SA 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 BISCOTTI SA come from?

All FDA import refusal data for BISCOTTI SA 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.