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Semilab Rt.

⚠️ Moderate Risk

FEI: 3003398928 • Budapest XI, Budapest • HUNGARY

FEI

FEI Number

3003398928

📍

Location

Budapest XI, Budapest

🇭🇺

Country

HUNGARY
🏢

Address

Prielle Kornelia utca 2., , Budapest XI, Budapest, Hungary

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/12/2003
Latest Refusal
9/12/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

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
9/12/2003
90IWEMONITOR, PATIENT POSITION, LIGHT-BEAM
476NO REGISTR
New York District Office (NYK-DO)

Frequently Asked Questions

What is Semilab Rt.'s FDA import refusal history?

Semilab Rt. (FEI: 3003398928) has 1 FDA import refusal record(s) in our database, spanning from 9/12/2003 to 9/12/2003.

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. Semilab Rt.'s FEI number is 3003398928.

What types of violations has Semilab Rt. received?

Semilab Rt. 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 Semilab Rt. come from?

All FDA import refusal data for Semilab Rt. 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.