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NINBEN CO., LTD.

⚠️ Moderate Risk

FEI: 3004303135 • Chuo, Tokyo • JAPAN

FEI

FEI Number

3004303135

📍

Location

Chuo, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

2 Chome 3-1, Nihonbashimuro-Machi, Chuo, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

45.5
LowModerateHighCritical

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

Statistics

7
Total Refusals
2
Unique Violations
4/30/2003
Latest Refusal
2/12/2003
Earliest Refusal

Score Breakdown

Violation Severity
71.1×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

837×

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.

2182×

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.

Refusal History

DateProductViolationsDivision
4/30/2003
25EGT99MIXED VEGETABLES, N.E.C.
218LIST INGRE
83NO PROCESS
Los Angeles District Office (LOS-DO)
4/30/2003
25EGT99MIXED VEGETABLES, N.E.C.
218LIST INGRE
83NO PROCESS
Los Angeles District Office (LOS-DO)
2/13/2003
37JGE99SAUCES, N.E.C.
83NO PROCESS
Los Angeles District Office (LOS-DO)
2/13/2003
37JGE99SAUCES, N.E.C.
83NO PROCESS
Los Angeles District Office (LOS-DO)
2/13/2003
37JCE99SAUCES, N.E.C.
83NO PROCESS
Los Angeles District Office (LOS-DO)
2/12/2003
25EGT99MIXED VEGETABLES, N.E.C.
83NO PROCESS
Los Angeles District Office (LOS-DO)
2/12/2003
25EGT99MIXED VEGETABLES, N.E.C.
83NO PROCESS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is NINBEN CO., LTD.'s FDA import refusal history?

NINBEN CO., LTD. (FEI: 3004303135) has 7 FDA import refusal record(s) in our database, spanning from 2/12/2003 to 4/30/2003.

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. NINBEN CO., LTD.'s FEI number is 3004303135.

What types of violations has NINBEN CO., LTD. received?

NINBEN CO., LTD. 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 NINBEN CO., LTD. come from?

All FDA import refusal data for NINBEN CO., LTD. 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.