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Gliatech EMCM Bv

⚠️ Moderate Risk

FEI: 3000147966 • Nijmegen, Gelderland • NETHERLANDS

FEI

FEI Number

3000147966

📍

Location

Nijmegen, Gelderland

🇳🇱
🏢

Address

Gerstweg 2, , Nijmegen, Gelderland, Netherlands

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/8/2001
Latest Refusal
10/8/2001
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
10/8/2001
89MLQINHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER)
2780DEVICEGMPS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Gliatech EMCM Bv's FDA import refusal history?

Gliatech EMCM Bv (FEI: 3000147966) has 1 FDA import refusal record(s) in our database, spanning from 10/8/2001 to 10/8/2001.

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. Gliatech EMCM Bv's FEI number is 3000147966.

What types of violations has Gliatech EMCM Bv received?

Gliatech EMCM Bv 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 Gliatech EMCM Bv come from?

All FDA import refusal data for Gliatech EMCM Bv 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.