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Biodes Espana

⚠️ Moderate Risk

FEI: 3001000531 • Ponferrada, Leon • SPAIN

FEI

FEI Number

3001000531

📍

Location

Ponferrada, Leon

🇪🇸

Country

SPAIN
🏢

Address

Avenida Del Conde De Los Gaitanes 1, , Ponferrada, Leon, Spain

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
1/22/2009
Latest Refusal
1/22/2009
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

4881×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
1/22/2009
66YBS99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
488HEALTH C
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Biodes Espana's FDA import refusal history?

Biodes Espana (FEI: 3001000531) has 1 FDA import refusal record(s) in our database, spanning from 1/22/2009 to 1/22/2009.

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. Biodes Espana's FEI number is 3001000531.

What types of violations has Biodes Espana received?

Biodes Espana 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 Biodes Espana come from?

All FDA import refusal data for Biodes Espana 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.