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Sklar

⚠️ Moderate Risk

FEI: 3002829334 • Tuttleingen • GERMANY

FEI

FEI Number

3002829334

📍

Location

Tuttleingen

🇩🇪

Country

GERMANY
🏢

Address

Plst At Fach, , Tuttleingen, , Germany

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/8/2006
Latest Refusal
6/8/2006
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

3413×

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
6/8/2006
77ENZTELESCOPE, LARYNGEAL-BRONCHIAL
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)
6/8/2006
79GENFORCEPS, GENERAL & PLASTIC SURGERY
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)
6/8/2006
79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Sklar's FDA import refusal history?

Sklar (FEI: 3002829334) has 3 FDA import refusal record(s) in our database, spanning from 6/8/2006 to 6/8/2006.

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. Sklar's FEI number is 3002829334.

What types of violations has Sklar received?

Sklar 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 Sklar come from?

All FDA import refusal data for Sklar 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.