ImportRefusal LogoImportRefusal

Kawamoto Corporation

⚠️ Moderate Risk

FEI: 5900 • Osaka, Osaka • JAPAN

FEI

FEI Number

5900

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

2 Chome 4-1 Kawaraya-Machi, Chuo; Kawaraya-Machi; Chuo, Osaka, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

37.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/7/2022
Latest Refusal
2/7/2022
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
7.4×20%
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

2901×

DE IMP GMP

The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).

Refusal History

DateProductViolationsDivision
2/7/2022
80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE
290DE IMP GMP
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Kawamoto Corporation's FDA import refusal history?

Kawamoto Corporation (FEI: 5900) has 1 FDA import refusal record(s) in our database, spanning from 2/7/2022 to 2/7/2022.

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. Kawamoto Corporation's FEI number is 5900.

What types of violations has Kawamoto Corporation received?

Kawamoto Corporation 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 Kawamoto Corporation come from?

All FDA import refusal data for Kawamoto 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.