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Agency for Medical Innovations GmbH

✅ Low Risk

FEI: 3005049530 • Feldkirch, Vorarlberg • AUSTRIA

FEI

FEI Number

3005049530

📍

Location

Feldkirch, Vorarlberg

🇦🇹

Country

AUSTRIA
🏢

Address

Im Letten 1, , Feldkirch, Vorarlberg, Austria

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/10/2006
Latest Refusal
4/10/2006
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
4/10/2006
79GENFORCEPS, GENERAL & PLASTIC SURGERY
118NOT LISTED
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Agency for Medical Innovations GmbH's FDA import refusal history?

Agency for Medical Innovations GmbH (FEI: 3005049530) has 1 FDA import refusal record(s) in our database, spanning from 4/10/2006 to 4/10/2006.

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. Agency for Medical Innovations GmbH's FEI number is 3005049530.

What types of violations has Agency for Medical Innovations GmbH received?

Agency for Medical Innovations GmbH has been cited for 2 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 Agency for Medical Innovations GmbH come from?

All FDA import refusal data for Agency for Medical Innovations GmbH 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.