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I-Ware Laboratory Co., Ltd.

⚠️ Moderate Risk

FEI: 3010402258 • Minoo, Osaka • JAPAN

FEI

FEI Number

3010402258

📍

Location

Minoo, Osaka

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 10-9 Mminoh Fureres Bldg., , Minoo, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/4/2014
Latest Refusal
9/4/2014
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
9/4/2014
95RHZ3D LASER SCANNING SYSTEM
476NO REGISTR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is I-Ware Laboratory Co., Ltd.'s FDA import refusal history?

I-Ware Laboratory Co., Ltd. (FEI: 3010402258) has 1 FDA import refusal record(s) in our database, spanning from 9/4/2014 to 9/4/2014.

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. I-Ware Laboratory Co., Ltd.'s FEI number is 3010402258.

What types of violations has I-Ware Laboratory Co., Ltd. received?

I-Ware Laboratory 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 I-Ware Laboratory Co., Ltd. come from?

All FDA import refusal data for I-Ware Laboratory 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.