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Uniwill Computer International

⚠️ Moderate Risk

FEI: 3003802203 • Fremont, CA • UNITED STATES

FEI

FEI Number

3003802203

📍

Location

Fremont, CA

🇺🇸
🏢

Address

3358 Gateway Blvd, , Fremont, CA, United States

Moderate Risk

FDA Import Risk Assessment

33.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/17/2006
Latest Refusal
9/12/2005
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
16.9×10%
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

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.

4761×

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
11/17/2006
95L22LASER PRODUCT FOR NON-MEDICAL USE
47NON STD
New Orleans District Office (NOL-DO)
9/12/2005
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Uniwill Computer International's FDA import refusal history?

Uniwill Computer International (FEI: 3003802203) has 2 FDA import refusal record(s) in our database, spanning from 9/12/2005 to 11/17/2006.

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. Uniwill Computer International's FEI number is 3003802203.

What types of violations has Uniwill Computer International received?

Uniwill Computer International 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 Uniwill Computer International come from?

All FDA import refusal data for Uniwill Computer International 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.