ImportRefusal LogoImportRefusal

Union Quimico Farmaceutica, SA

✅ Low Risk

FEI: 3000241004 • Barcelona, Barcelona • SPAIN

FEI

FEI Number

3000241004

📍

Location

Barcelona, Barcelona

🇪🇸

Country

SPAIN
🏢

Address

Calle Mallorca 262, , Barcelona, Barcelona, Spain

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
7/13/2016
Latest Refusal
7/13/2016
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
7/13/2016
56JDR31CLINDAMYCIN PHOSPHATE (LINCOMYCINS)
3280FRNMFGREG
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Union Quimico Farmaceutica, SA's FDA import refusal history?

Union Quimico Farmaceutica, SA (FEI: 3000241004) has 1 FDA import refusal record(s) in our database, spanning from 7/13/2016 to 7/13/2016.

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. Union Quimico Farmaceutica, SA's FEI number is 3000241004.

What types of violations has Union Quimico Farmaceutica, SA received?

Union Quimico Farmaceutica, SA 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 Union Quimico Farmaceutica, SA come from?

All FDA import refusal data for Union Quimico Farmaceutica, SA 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.