ImportRefusal LogoImportRefusal

Kewpie, Inc.

⚠️ Moderate Risk

FEI: 3004314826 • Shibuya-ku, Tokyo-to • JAPAN

FEI

FEI Number

3004314826

📍

Location

Shibuya-ku, Tokyo-to

🇯🇵

Country

JAPAN
🏢

Address

1 4 13 Shibutani, , Shibuya-ku, Tokyo-to, Japan

Moderate Risk

FDA Import Risk Assessment

40.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
3
Unique Violations
5/4/2007
Latest Refusal
9/4/2002
Earliest Refusal

Score Breakdown

Violation Severity
77.3×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
10.7×10%
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

625×

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).

835×

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.

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Refusal History

DateProductViolationsDivision
5/4/2007
37JGT99SAUCES, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
7/14/2005
02DGT99RICE, PROCESSED (PACKAGED) N.E.C.
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
7/14/2005
02DGT99RICE, PROCESSED (PACKAGED) N.E.C.
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
7/14/2005
02DGT99RICE, PROCESSED (PACKAGED) N.E.C.
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
9/4/2002
27AGT02MAYONNAISE
260FALSE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Kewpie, Inc.'s FDA import refusal history?

Kewpie, Inc. (FEI: 3004314826) has 5 FDA import refusal record(s) in our database, spanning from 9/4/2002 to 5/4/2007.

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. Kewpie, Inc.'s FEI number is 3004314826.

What types of violations has Kewpie, Inc. received?

Kewpie, Inc. 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 Kewpie, Inc. come from?

All FDA import refusal data for Kewpie, Inc. 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.