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Laytec In-Line Gmbh

⚠️ Moderate Risk

FEI: 3009043595 • Berlin, Berlin • GERMANY

FEI

FEI Number

3009043595

📍

Location

Berlin, Berlin

🇩🇪

Country

GERMANY
🏢

Address

Seesener Strasse 10-13, , Berlin, Berlin, Germany

Moderate Risk

FDA Import Risk Assessment

43.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
11/26/2025
Latest Refusal
11/26/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
97.5×20%
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

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

4761×

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
11/26/2025
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
333LACKS FIRM
47NON STD
476NO REGISTR
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Laytec In-Line Gmbh's FDA import refusal history?

Laytec In-Line Gmbh (FEI: 3009043595) has 1 FDA import refusal record(s) in our database, spanning from 11/26/2025 to 11/26/2025.

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. Laytec In-Line Gmbh's FEI number is 3009043595.

What types of violations has Laytec In-Line Gmbh received?

Laytec In-Line Gmbh has been cited for 3 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 Laytec In-Line Gmbh come from?

All FDA import refusal data for Laytec In-Line 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.