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Laetus Gmbh

⚠️ Moderate Risk

FEI: 3006727495 • Alsbach-Hahnlein, Hesse • GERMANY

FEI

FEI Number

3006727495

📍

Location

Alsbach-Hahnlein, Hesse

🇩🇪

Country

GERMANY
🏢

Address

Sandwiesenstr. 27, , Alsbach-Hahnlein, Hesse, Germany

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

7
Total Refusals
1
Unique Violations
3/4/2014
Latest Refusal
6/24/2008
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
12.3×10%
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

4767×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
3/4/2014
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
New York District Office (NYK-DO)
3/4/2014
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
New York District Office (NYK-DO)
3/4/2014
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
New York District Office (NYK-DO)
10/2/2013
95RDZLOW-POWER LASER LIGHT SHOW PROJECTOR, DISPLAY PRODUCTS
476NO REGISTR
Division of Northern Border Imports (DNBI)
10/2/2013
95RHYLASER SENSING SYSTEM
476NO REGISTR
Division of Northern Border Imports (DNBI)
3/7/2012
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
New Orleans District Office (NOL-DO)
6/24/2008
95RDZLOW-POWER LASER LIGHT SHOW PROJECTOR, DISPLAY PRODUCTS
476NO REGISTR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laetus Gmbh's FDA import refusal history?

Laetus Gmbh (FEI: 3006727495) has 7 FDA import refusal record(s) in our database, spanning from 6/24/2008 to 3/4/2014.

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. Laetus Gmbh's FEI number is 3006727495.

What types of violations has Laetus Gmbh received?

Laetus Gmbh 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 Laetus Gmbh come from?

All FDA import refusal data for Laetus 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.