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Eplus Premium Ltd.

⚠️ Moderate Risk

FEI: 3007896772 • Xindian • TAIWAN

FEI

FEI Number

3007896772

📍

Location

Xindian

🇹🇼

Country

TAIWAN
🏢

Address

6f No 85-55 Anxing Rd, , Xindian, , Taiwan

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/30/2009
Latest Refusal
10/30/2009
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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.

471×

NON STD

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 offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
10/30/2009
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
16DIRECTIONS
47NON STD
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Eplus Premium Ltd.'s FDA import refusal history?

Eplus Premium Ltd. (FEI: 3007896772) has 1 FDA import refusal record(s) in our database, spanning from 10/30/2009 to 10/30/2009.

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. Eplus Premium Ltd.'s FEI number is 3007896772.

What types of violations has Eplus Premium Ltd. received?

Eplus Premium 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 Eplus Premium Ltd. come from?

All FDA import refusal data for Eplus Premium 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.