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Imperial Seivaku Co., LTD

✅ Low Risk

FEI: 3015212510 • Choselamoto 2--8-27 • JAPAN

FEI

FEI Number

3015212510

📍

Location

Choselamoto 2--8-27

🇯🇵

Country

JAPAN
🏢

Address

Hyoro-ken Amagakaki-shi, , Choselamoto 2--8-27, , Japan

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
6/27/2019
Latest Refusal
6/27/2019
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
6/27/2019
66CDY99STOOL SOFTENER N.E.C.
3260NO ENGLISH
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Imperial Seivaku Co., LTD's FDA import refusal history?

Imperial Seivaku Co., LTD (FEI: 3015212510) has 1 FDA import refusal record(s) in our database, spanning from 6/27/2019 to 6/27/2019.

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. Imperial Seivaku Co., LTD's FEI number is 3015212510.

What types of violations has Imperial Seivaku Co., LTD received?

Imperial Seivaku Co., LTD has been cited for 1 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 Imperial Seivaku Co., LTD come from?

All FDA import refusal data for Imperial Seivaku 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.