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Universitat Autonoma de Barcelona (UAB)

⚠️ Moderate Risk

FEI: 3011905138 • Cerdanyola Del Valles, Barcelona • SPAIN

FEI

FEI Number

3011905138

📍

Location

Cerdanyola Del Valles, Barcelona

🇪🇸

Country

SPAIN
🏢

Address

Plaza Civica, , Cerdanyola Del Valles, Barcelona, Spain

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/31/2017
Latest Refusal
5/31/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

711×

NO LICENSE

The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use

Refusal History

DateProductViolationsDivision
5/31/2017
57YI99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.
71NO LICENSE
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Universitat Autonoma de Barcelona (UAB)'s FDA import refusal history?

Universitat Autonoma de Barcelona (UAB) (FEI: 3011905138) has 1 FDA import refusal record(s) in our database, spanning from 5/31/2017 to 5/31/2017.

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. Universitat Autonoma de Barcelona (UAB)'s FEI number is 3011905138.

What types of violations has Universitat Autonoma de Barcelona (UAB) received?

Universitat Autonoma de Barcelona (UAB) 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 Universitat Autonoma de Barcelona (UAB) come from?

All FDA import refusal data for Universitat Autonoma de Barcelona (UAB) 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.