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Lindberg A/S

✅ Low Risk

FEI: 3003093025 • AABYHOJ, Midtjylland • DENMARK

FEI

FEI Number

3003093025

📍

Location

AABYHOJ, Midtjylland

🇩🇰

Country

DENMARK
🏢

Address

40C Frichsparken, 30 BJARKESVEJ, AABYHOJ, Midtjylland, Denmark

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
5/11/2016
Latest Refusal
1/23/2009
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
5.5×10%
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

3414×

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
5/11/2016
86HQZFRAME, SPECTACLE
341REGISTERED
New York District Office (NYK-DO)
5/11/2016
86HQZFRAME, SPECTACLE
341REGISTERED
New York District Office (NYK-DO)
5/11/2016
86HQZFRAME, SPECTACLE
341REGISTERED
New York District Office (NYK-DO)
1/23/2009
86HPAFRAME, TRIAL, OPHTHALMIC
341REGISTERED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Lindberg A/S's FDA import refusal history?

Lindberg A/S (FEI: 3003093025) has 4 FDA import refusal record(s) in our database, spanning from 1/23/2009 to 5/11/2016.

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. Lindberg A/S's FEI number is 3003093025.

What types of violations has Lindberg A/S received?

Lindberg A/S 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 Lindberg A/S come from?

All FDA import refusal data for Lindberg A/S 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.