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CHIU FU YU CO., LTD.

✅ Low Risk

FEI: 3017822099 • Changhua • TAIWAN

FEI

FEI Number

3017822099

📍

Location

Changhua

🇹🇼

Country

TAIWAN
🏢

Address

Fu-An Rd., No. 155 Sihu Township, Changhua, , 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
2/26/2021
Latest Refusal
2/26/2021
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
2/26/2021
80QMFMASK, SURGICAL, EUA AUTHORIZED
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CHIU FU YU CO., LTD.'s FDA import refusal history?

CHIU FU YU CO., LTD. (FEI: 3017822099) has 1 FDA import refusal record(s) in our database, spanning from 2/26/2021 to 2/26/2021.

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. CHIU FU YU CO., LTD.'s FEI number is 3017822099.

What types of violations has CHIU FU YU CO., LTD. received?

CHIU FU YU 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 CHIU FU YU CO., LTD. come from?

All FDA import refusal data for CHIU FU YU 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.