Lawton Gmbh & Co. Kg
⚠️ Moderate Risk
FEI: 3002807449 • Tuttlingen, Baden-Wurttemberg • GERMANY
FEI Number
3002807449
Location
Tuttlingen, Baden-Wurttemberg
Country
GERMANYAddress
Bahnhofstr. 124, , Tuttlingen, Baden-Wurttemberg, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2005 | 85HFXCLAMP, CIRCUMCISION | 508NO 510(K) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Lawton Gmbh & Co. Kg's FDA import refusal history?
Lawton Gmbh & Co. Kg (FEI: 3002807449) has 1 FDA import refusal record(s) in our database, spanning from 1/31/2005 to 1/31/2005.
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. Kg's FEI number is 3002807449.
What types of violations has Lawton Gmbh & Co. Kg received?
Lawton Gmbh & Co. Kg 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. Kg come from?
All FDA import refusal data for Lawton Gmbh & Co. Kg 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.