ImportRefusal LogoImportRefusal

LIGHT GEAR TECHNOLOGY CO.,LTD.

✅ Low Risk

FEI: 3014288394 • New Taipei City • TAIWAN

FEI

FEI Number

3014288394

📍

Location

New Taipei City

🇹🇼

Country

TAIWAN
🏢

Address

Hsin Chuang City, Lane 829; No. 45 Zhongzheng Rd.; Xinzhuang Dist., New Taipei City, , 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
2
Unique Violations
5/23/2018
Latest Refusal
5/23/2018
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

2781×

NO TAG

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

Refusal History

DateProductViolationsDivision
5/23/2018
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
16DIRECTIONS
278NO TAG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is LIGHT GEAR TECHNOLOGY CO.,LTD.'s FDA import refusal history?

LIGHT GEAR TECHNOLOGY CO.,LTD. (FEI: 3014288394) has 1 FDA import refusal record(s) in our database, spanning from 5/23/2018 to 5/23/2018.

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. LIGHT GEAR TECHNOLOGY CO.,LTD.'s FEI number is 3014288394.

What types of violations has LIGHT GEAR TECHNOLOGY CO.,LTD. received?

LIGHT GEAR TECHNOLOGY CO.,LTD. has been cited for 2 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 LIGHT GEAR TECHNOLOGY CO.,LTD. come from?

All FDA import refusal data for LIGHT GEAR TECHNOLOGY 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.