ImportRefusal LogoImportRefusal

UCB Biosciences Inc.

⚠️ Moderate Risk

FEI: 3011290762 • Smyrna, GA • UNITED STATES

FEI

FEI Number

3011290762

📍

Location

Smyrna, GA

🇺🇸
🏢

Address

1950 Lake Park Dr SE, , Smyrna, GA, United States

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/5/2012
Latest Refusal
3/2/2012
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1792×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

Refusal History

DateProductViolationsDivision
3/5/2012
61MCB42LEVETIRACETAM (ANTI-CONVULSANT)
179AGR RX
New Orleans District Office (NOL-DO)
3/2/2012
61MIY42LEVETIRACETAM (ANTI-CONVULSANT)
179AGR RX
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is UCB Biosciences Inc.'s FDA import refusal history?

UCB Biosciences Inc. (FEI: 3011290762) has 2 FDA import refusal record(s) in our database, spanning from 3/2/2012 to 3/5/2012.

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. UCB Biosciences Inc.'s FEI number is 3011290762.

What types of violations has UCB Biosciences Inc. received?

UCB Biosciences Inc. 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 UCB Biosciences Inc. come from?

All FDA import refusal data for UCB Biosciences Inc. 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.