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Lawton Gmbh & Co

⚠️ Moderate Risk

FEI: 3003202479 • Fridingen an der Donau, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3003202479

📍

Location

Fridingen an der Donau, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Wurttembergerstr. 23, , Fridingen an der Donau, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

25.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
10/3/2001
Latest Refusal
10/3/2001
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

3415×

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
10/3/2001
87HTXRONGEUR
341REGISTERED
Los Angeles District Office (LOS-DO)
10/3/2001
79FZSCURETTE, SURGICAL
341REGISTERED
Los Angeles District Office (LOS-DO)
10/3/2001
79GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
341REGISTERED
Los Angeles District Office (LOS-DO)
10/3/2001
79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
341REGISTERED
Los Angeles District Office (LOS-DO)
10/3/2001
76EMMCHISEL, OSTEOTOME, SURGICAL
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Lawton Gmbh & Co's FDA import refusal history?

Lawton Gmbh & Co (FEI: 3003202479) has 5 FDA import refusal record(s) in our database, spanning from 10/3/2001 to 10/3/2001.

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. Lawton Gmbh & Co's FEI number is 3003202479.

What types of violations has Lawton Gmbh & Co received?

Lawton Gmbh & Co 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 Lawton Gmbh & Co come from?

All FDA import refusal data for Lawton Gmbh & Co 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.