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Intai Technology Corp. Implants Business Unit

✅ Low Risk

FEI: 3011187779 • Taichung City • TAIWAN

FEI

FEI Number

3011187779

📍

Location

Taichung City

🇹🇼

Country

TAIWAN
🏢

Address

Nantun District, No. 9 Jingke Rd.; Nantun Dist., Taichung City, , Taiwan

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
3/8/2011
Latest Refusal
3/8/2011
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
3/8/2011
87HWCSCREW, FIXATION, BONE
341REGISTERED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Intai Technology Corp. Implants Business Unit's FDA import refusal history?

Intai Technology Corp. Implants Business Unit (FEI: 3011187779) has 1 FDA import refusal record(s) in our database, spanning from 3/8/2011 to 3/8/2011.

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. Intai Technology Corp. Implants Business Unit's FEI number is 3011187779.

What types of violations has Intai Technology Corp. Implants Business Unit received?

Intai Technology Corp. Implants Business Unit 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 Intai Technology Corp. Implants Business Unit come from?

All FDA import refusal data for Intai Technology Corp. Implants Business Unit 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.