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Kai Industries Co., Ltd.

⚠️ Moderate Risk

FEI: 6827 • Seki, Gifu • JAPAN

FEI

FEI Number

6827

📍

Location

Seki, Gifu

🇯🇵

Country

JAPAN
🏢

Address

Kaiindasutorizu ( Kabu ), 1110 Gihu; Oyana; Oyana, Seki, Gifu, Japan

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
6/24/2016
Latest Refusal
6/24/2016
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

32803×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
6/24/2016
79GDXSCALPEL, ONE-PIECE
3280FRNMFGREG
Florida District Office (FLA-DO)
6/24/2016
79FZSCURETTE, SURGICAL
3280FRNMFGREG
Florida District Office (FLA-DO)
6/24/2016
79LRYPUNCH, SURGICAL
3280FRNMFGREG
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Kai Industries Co., Ltd.'s FDA import refusal history?

Kai Industries Co., Ltd. (FEI: 6827) has 3 FDA import refusal record(s) in our database, spanning from 6/24/2016 to 6/24/2016.

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. Kai Industries Co., Ltd.'s FEI number is 6827.

What types of violations has Kai Industries Co., Ltd. received?

Kai Industries 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 Kai Industries Co., Ltd. come from?

All FDA import refusal data for Kai Industries 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.