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Bionime Corporation

✅ Low Risk

FEI: 3010543913 • Taichungtaichung • TAIWAN

FEI

FEI Number

3010543913

📍

Location

Taichungtaichung

🇹🇼

Country

TAIWAN
🏢

Address

Daqing St, Sec 2, NO 100 South Dist, Taichungtaichung, , Taiwan

Low Risk

FDA Import Risk Assessment

23.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
2/11/2020
Latest Refusal
2/11/2020
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

3414×

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
2/11/2020
75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
341REGISTERED
Division of Southeast Imports (DSEI)
2/11/2020
75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
341REGISTERED
Division of Southeast Imports (DSEI)
2/11/2020
75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
341REGISTERED
Division of Southeast Imports (DSEI)
2/11/2020
75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Bionime Corporation's FDA import refusal history?

Bionime Corporation (FEI: 3010543913) has 4 FDA import refusal record(s) in our database, spanning from 2/11/2020 to 2/11/2020.

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. Bionime Corporation's FEI number is 3010543913.

What types of violations has Bionime Corporation received?

Bionime Corporation 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 Bionime Corporation come from?

All FDA import refusal data for Bionime Corporation 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.