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Bisinternational

⚠️ High Risk

FEI: 3010784681 • Priolo G, SR • ITALY

FEI

FEI Number

3010784681

📍

Location

Priolo G, SR

🇮🇹

Country

ITALY
🏢

Address

Via Pentapoli 9, , Priolo G, SR, Italy

High Risk

FDA Import Risk Assessment

54.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

13
Total Refusals
2
Unique Violations
6/18/2008
Latest Refusal
3/12/2007
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
42.5×30%
Recency
0.0×20%
Frequency
100.0×10%
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

8313×

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.

624×

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
6/18/2008
27YCO99CONDIMENTS, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
6/18/2008
24HCO01EGG PLANT, DRIED OR PASTE
83NO PROCESS
San Francisco District Office (SAN-DO)
6/18/2008
24UCO01ARTICHOKE, DRIED OR PASTE
83NO PROCESS
San Francisco District Office (SAN-DO)
6/18/2008
37JCY99SAUCES, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
6/18/2008
37JHY99SAUCES, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
6/18/2008
27YCO99CONDIMENTS, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
6/18/2008
37BCO99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
5/19/2008
37BCO99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
5/19/2008
37BCO99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
5/19/2008
37BCO99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
5/19/2008
37BCO99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
10/4/2007
21HCT09OLIVES, DRIED OR PASTE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
3/12/2007
27YCE06PEPPER SAUCE (HOT, MILD, ETC.)
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Bisinternational's FDA import refusal history?

Bisinternational (FEI: 3010784681) has 13 FDA import refusal record(s) in our database, spanning from 3/12/2007 to 6/18/2008.

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. Bisinternational's FEI number is 3010784681.

What types of violations has Bisinternational received?

Bisinternational 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 Bisinternational come from?

All FDA import refusal data for Bisinternational 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.