Andscon Ltd
✅ Low Risk
FEI: 3011401813 • Aldershot, Hampshire • UNITED KINGDOM
FEI Number
3011401813
Location
Aldershot, Hampshire
Country
UNITED KINGDOMAddress
4 Hillside Road, , Aldershot, Hampshire, United Kingdom
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 |
|---|---|---|---|
| 5/1/2015 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | 341REGISTERED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Andscon Ltd's FDA import refusal history?
Andscon Ltd (FEI: 3011401813) has 1 FDA import refusal record(s) in our database, spanning from 5/1/2015 to 5/1/2015.
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. Andscon Ltd's FEI number is 3011401813.
What types of violations has Andscon Ltd received?
Andscon Ltd 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 Andscon Ltd come from?
All FDA import refusal data for Andscon Ltd 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.