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New Atico International Ltd. Taiwan Branch

✅ Low Risk

FEI: 1000110640 • Taipei • TAIWAN

FEI

FEI Number

1000110640

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

245, 6 F, Tung Hwa South Rd Sec 1, Taipei, , Taiwan

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/17/2001
Latest Refusal
11/17/2001
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
11/17/2001
79LRRKIT, FIRST AID
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is New Atico International Ltd. Taiwan Branch's FDA import refusal history?

New Atico International Ltd. Taiwan Branch (FEI: 1000110640) has 1 FDA import refusal record(s) in our database, spanning from 11/17/2001 to 11/17/2001.

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. New Atico International Ltd. Taiwan Branch's FEI number is 1000110640.

What types of violations has New Atico International Ltd. Taiwan Branch received?

New Atico International Ltd. Taiwan Branch 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 New Atico International Ltd. Taiwan Branch come from?

All FDA import refusal data for New Atico International Ltd. Taiwan Branch 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.