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BD FRAGA

⚠️ Moderate Risk

FEI: 3027625536 • Fraga • SPAIN

FEI

FEI Number

3027625536

📍

Location

Fraga

🇪🇸

Country

SPAIN
🏢

Address

Becton Dickinson Sa Crt, , Fraga, , Spain

Moderate Risk

FDA Import Risk Assessment

34.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/23/2023
Latest Refusal
8/23/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
51.7×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
8/23/2023
80KZHINTRODUCER, SYRINGE NEEDLE
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BD FRAGA's FDA import refusal history?

BD FRAGA (FEI: 3027625536) has 1 FDA import refusal record(s) in our database, spanning from 8/23/2023 to 8/23/2023.

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. BD FRAGA's FEI number is 3027625536.

What types of violations has BD FRAGA received?

BD FRAGA 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 BD FRAGA come from?

All FDA import refusal data for BD FRAGA 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.