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FRANZESE S.P.A.

⚠️ Moderate Risk

FEI: 3004329625 • Palma Campania, Naples • ITALY

FEI

FEI Number

3004329625

📍

Location

Palma Campania, Naples

🇮🇹

Country

ITALY
🏢

Address

Via Circumvallazione N. 75, , Palma Campania, Naples, Italy

Moderate Risk

FDA Import Risk Assessment

39.2
LowModerateHighCritical

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

Statistics

13
Total Refusals
5
Unique Violations
7/30/2015
Latest Refusal
9/12/2002
Earliest Refusal

Score Breakdown

Violation Severity
63.6×40%
Refusal Volume
42.5×30%
Recency
0.0×20%
Frequency
10.1×10%
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

8310×

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.

3213×

LACKS N/C

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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

33203×

TRANSFAT

The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].

4823×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

623×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

Refusal History

DateProductViolationsDivision
7/30/2015
24CEE06CHICK PEA, WITH SAUCE
321LACKS N/C
3320TRANSFAT
482NUTRIT LBL
Florida District Office (FLA-DO)
7/30/2015
24CEE06CHICK PEA, WITH SAUCE
321LACKS N/C
3320TRANSFAT
482NUTRIT LBL
Florida District Office (FLA-DO)
7/30/2015
24AEE99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE)
321LACKS N/C
3320TRANSFAT
482NUTRIT LBL
Florida District Office (FLA-DO)
7/10/2014
24AEE99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE)
83NO PROCESS
New York District Office (NYK-DO)
9/24/2013
24AEE99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE)
83NO PROCESS
New York District Office (NYK-DO)
8/21/2012
24AEE99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE)
83NO PROCESS
Florida District Office (FLA-DO)
8/21/2012
25EEE99MIXED VEGETABLES, N.E.C.
83NO PROCESS
Florida District Office (FLA-DO)
7/19/2011
24AEE17PIGEON PEAS
83NO PROCESS
Florida District Office (FLA-DO)
11/13/2008
24AEI99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE)
83NO PROCESS
Baltimore District Office (BLT-DO)
2/20/2003
24AEE07KIDNEY BEAN
83NO PROCESS
New York District Office (NYK-DO)
2/11/2003
24AEE16BLACK BEANS
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)
1/10/2003
24AEE07KIDNEY BEAN
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)
9/12/2002
24AET07KIDNEY BEAN
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)

Frequently Asked Questions

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

FRANZESE S.P.A. (FEI: 3004329625) has 13 FDA import refusal record(s) in our database, spanning from 9/12/2002 to 7/30/2015.

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. FRANZESE S.P.A.'s FEI number is 3004329625.

What types of violations has FRANZESE S.P.A. received?

FRANZESE S.P.A. has been cited for 5 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 FRANZESE S.P.A. come from?

All FDA import refusal data for FRANZESE 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.