ImportRefusal LogoImportRefusal

Austar Hearing Science And Tech Xiamen Co

✅ Low Risk

FEI: 3010582610 • Xiamen • CHINA

FEI

FEI Number

3010582610

📍

Location

Xiamen

🇨🇳

Country

CHINA
🏢

Address

Floor 2 No 2, Gaoqi South 12th Rd Huli, , Xiamen, , China

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
2/3/2014
Latest Refusal
2/3/2014
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
2/3/2014
77ESDHEARING-AID, AIR-CONDUCTION
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Austar Hearing Science And Tech Xiamen Co's FDA import refusal history?

Austar Hearing Science And Tech Xiamen Co (FEI: 3010582610) has 1 FDA import refusal record(s) in our database, spanning from 2/3/2014 to 2/3/2014.

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. Austar Hearing Science And Tech Xiamen Co's FEI number is 3010582610.

What types of violations has Austar Hearing Science And Tech Xiamen Co received?

Austar Hearing Science And Tech Xiamen Co 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 Austar Hearing Science And Tech Xiamen Co come from?

All FDA import refusal data for Austar Hearing Science And Tech Xiamen Co 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.