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Medtronic Bakken Research Center B.V.

✅ Low Risk

FEI: 3003276151 • Maastricht, Limburg • NETHERLANDS

FEI

FEI Number

3003276151

📍

Location

Maastricht, Limburg

🇳🇱
🏢

Address

Endepolsdomein 5, , Maastricht, Limburg, Netherlands

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
3/30/2017
Latest Refusal
3/30/2017
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
3/30/2017
65PCA02SILDENAFIL CITRATE (REGULATOR)
3280FRNMFGREG
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Medtronic Bakken Research Center B.V.'s FDA import refusal history?

Medtronic Bakken Research Center B.V. (FEI: 3003276151) has 1 FDA import refusal record(s) in our database, spanning from 3/30/2017 to 3/30/2017.

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. Medtronic Bakken Research Center B.V.'s FEI number is 3003276151.

What types of violations has Medtronic Bakken Research Center B.V. received?

Medtronic Bakken Research Center B.V. 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 Medtronic Bakken Research Center B.V. come from?

All FDA import refusal data for Medtronic Bakken Research Center B.V. 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.