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Spi Transact

⚠️ Moderate Risk

FEI: 3004951475 • Westmont, IL • UNITED STATES

FEI

FEI Number

3004951475

📍

Location

Westmont, IL

🇺🇸
🏢

Address

700 E Ogden Ave Ste 207, , Westmont, IL, United States

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/27/2006
Latest Refusal
3/27/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

1262×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
3/27/2006
94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR
126FAILS STD
Southwest Import District Office (SWI-DO)
3/27/2006
95L22LASER PRODUCT FOR NON-MEDICAL USE
126FAILS STD
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Spi Transact's FDA import refusal history?

Spi Transact (FEI: 3004951475) has 2 FDA import refusal record(s) in our database, spanning from 3/27/2006 to 3/27/2006.

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. Spi Transact's FEI number is 3004951475.

What types of violations has Spi Transact received?

Spi Transact 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 Spi Transact come from?

All FDA import refusal data for Spi Transact 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.