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Dongguan Albatronics (Far East) Electronics Co. Ltc.

⚠️ Moderate Risk

FEI: 1000655118 • Guangdong • CHINA

FEI

FEI Number

1000655118

📍

Location

Guangdong

🇨🇳

Country

CHINA
🏢

Address

Lianzhou District, Shatin, Dongguan, , Guangdong, , China

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/10/2003
Latest Refusal
3/10/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4762×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
3/10/2003
97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE
476NO REGISTR
Los Angeles District Office (LOS-DO)
3/10/2003
97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE
476NO REGISTR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Dongguan Albatronics (Far East) Electronics Co. Ltc.'s FDA import refusal history?

Dongguan Albatronics (Far East) Electronics Co. Ltc. (FEI: 1000655118) has 2 FDA import refusal record(s) in our database, spanning from 3/10/2003 to 3/10/2003.

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. Dongguan Albatronics (Far East) Electronics Co. Ltc.'s FEI number is 1000655118.

What types of violations has Dongguan Albatronics (Far East) Electronics Co. Ltc. received?

Dongguan Albatronics (Far East) Electronics Co. Ltc. 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 Dongguan Albatronics (Far East) Electronics Co. Ltc. come from?

All FDA import refusal data for Dongguan Albatronics (Far East) Electronics Co. Ltc. 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.