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TOKYO KIKAKU HANBAI CO., LTD.

⚠️ Moderate Risk

FEI: 2000039848 • Kodaira, Tokyo • JAPAN

FEI

FEI Number

2000039848

📍

Location

Kodaira, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

2 Chome 835-5, Onuma-Cho, Kodaira, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/26/2012
Latest Refusal
9/26/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
9/26/2012
66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is TOKYO KIKAKU HANBAI CO., LTD.'s FDA import refusal history?

TOKYO KIKAKU HANBAI CO., LTD. (FEI: 2000039848) has 1 FDA import refusal record(s) in our database, spanning from 9/26/2012 to 9/26/2012.

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. TOKYO KIKAKU HANBAI CO., LTD.'s FEI number is 2000039848.

What types of violations has TOKYO KIKAKU HANBAI CO., LTD. received?

TOKYO KIKAKU HANBAI 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 TOKYO KIKAKU HANBAI CO., LTD. come from?

All FDA import refusal data for TOKYO KIKAKU HANBAI 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.