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SKF

⚠️ Moderate Risk

FEI: 3026997894 • Schweinfurt • GERMANY

FEI

FEI Number

3026997894

📍

Location

Schweinfurt

🇩🇪

Country

GERMANY
🏢

Address

Werk 1 Gunnar Wester St, , Schweinfurt, , Germany

Moderate Risk

FDA Import Risk Assessment

35.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/20/2024
Latest Refusal
3/20/2024
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
11.2×30%
Recency
63.8×20%
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

2781×

NO TAG

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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

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
3/20/2024
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
278NO TAG
476NO REGISTR
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is SKF's FDA import refusal history?

SKF (FEI: 3026997894) has 1 FDA import refusal record(s) in our database, spanning from 3/20/2024 to 3/20/2024.

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. SKF's FEI number is 3026997894.

What types of violations has SKF received?

SKF 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 SKF come from?

All FDA import refusal data for SKF 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.