Capp As
✅ Low Risk
FEI: 3005841212 • Denmark • DENMARK
FEI Number
3005841212
Location
Denmark
Country
DENMARKAddress
10 Landerussvej Dk5260 Odense S, , Denmark, , Denmark
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/25/2006 | 81GJGPIPETTE, QUANTITATIVE, HEMATOLOGY | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Capp As's FDA import refusal history?
Capp As (FEI: 3005841212) has 1 FDA import refusal record(s) in our database, spanning from 8/25/2006 to 8/25/2006.
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. Capp As's FEI number is 3005841212.
What types of violations has Capp As received?
Capp As 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 Capp As come from?
All FDA import refusal data for Capp As 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.