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Oritech Electronics Corp. Suite 7, 9

⚠️ Moderate Risk

FEI: 3007968205 • Taipei • TAIWAN

FEI

FEI Number

3007968205

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

16 Nanking E. Rd. Sec 5, , Taipei, , Taiwan

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/1/2010
Latest Refusal
4/1/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

2882×

STD LABEL

The article appears to not bear labeling prescribed by the performance standard established under section 514.

Refusal History

DateProductViolationsDivision
4/1/2010
79LRWSCISSORS, GENERAL USE, SURGICAL
288STD LABEL
New York District Office (NYK-DO)
4/1/2010
79LRWSCISSORS, GENERAL USE, SURGICAL
288STD LABEL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Oritech Electronics Corp. Suite 7, 9's FDA import refusal history?

Oritech Electronics Corp. Suite 7, 9 (FEI: 3007968205) has 2 FDA import refusal record(s) in our database, spanning from 4/1/2010 to 4/1/2010.

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. Oritech Electronics Corp. Suite 7, 9's FEI number is 3007968205.

What types of violations has Oritech Electronics Corp. Suite 7, 9 received?

Oritech Electronics Corp. Suite 7, 9 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 Oritech Electronics Corp. Suite 7, 9 come from?

All FDA import refusal data for Oritech Electronics Corp. Suite 7, 9 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.