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Nippon Del Monte Corporation

⚠️ Moderate Risk

FEI: 3007057764 • Numata, Gunma • JAPAN

FEI

FEI Number

3007057764

📍

Location

Numata, Gunma

🇯🇵

Country

JAPAN
🏢

Address

3748, Shimizu-Cho, Numata, Gunma, Japan

Moderate Risk

FDA Import Risk Assessment

46.3
LowModerateHighCritical

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

Statistics

13
Total Refusals
3
Unique Violations
4/23/2015
Latest Refusal
3/2/2004
Earliest Refusal

Score Breakdown

Violation Severity
80.9×40%
Refusal Volume
42.5×30%
Recency
0.0×20%
Frequency
11.7×10%
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

8312×

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.

629×

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).

24201×

RADIONUC

Article appears to contain the radionuclide, Cesium-137, a poisonous and deleterious substance which may render it injurious to health.

Refusal History

DateProductViolationsDivision
4/23/2015
25SGT01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C.
2420RADIONUC
Los Angeles District Office (LOS-DO)
8/12/2011
37JHE99SAUCES, N.E.C.
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
8/12/2011
37JHP07STEAK AND OTHER MEAT SAUCE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
12/1/2008
37JHT99SAUCES, N.E.C.
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
12/1/2008
37JHP07STEAK AND OTHER MEAT SAUCE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
11/3/2008
37JCT03CHILI SAUCE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
11/3/2008
37JHT99SAUCES, N.E.C.
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
11/3/2008
37JHP07STEAK AND OTHER MEAT SAUCE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
8/12/2008
37JHT99SAUCES, N.E.C.
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
11/29/2007
25ECO99MIXED VEGETABLES, N.E.C.
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)
10/18/2007
31KGT02TEA, GREEN
83NO PROCESS
New York District Office (NYK-DO)
3/2/2004
31KHE20TEA, LIQUID
83NO PROCESS
San Francisco District Office (SAN-DO)
3/2/2004
31KHE20TEA, LIQUID
83NO PROCESS
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Nippon Del Monte Corporation's FDA import refusal history?

Nippon Del Monte Corporation (FEI: 3007057764) has 13 FDA import refusal record(s) in our database, spanning from 3/2/2004 to 4/23/2015.

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. Nippon Del Monte Corporation's FEI number is 3007057764.

What types of violations has Nippon Del Monte Corporation received?

Nippon Del Monte Corporation has been cited for 3 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 Nippon Del Monte Corporation come from?

All FDA import refusal data for Nippon Del Monte Corporation 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.