EDINBURGH GENETICS LTD
⚠️ Moderate Risk
FEI: 3016782710 • Edinburgh, EDH • UNITED KINGDOM
FEI Number
3016782710
Location
Edinburgh, EDH
Country
UNITED KINGDOMAddress
64a Cumberland Street, Edh, Edinburgh, EDH, United Kingdom
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 |
|---|---|---|---|
| 1/5/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 1/4/2021 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 8/14/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is EDINBURGH GENETICS LTD's FDA import refusal history?
EDINBURGH GENETICS LTD (FEI: 3016782710) has 3 FDA import refusal record(s) in our database, spanning from 8/14/2020 to 1/5/2021.
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. EDINBURGH GENETICS LTD's FEI number is 3016782710.
What types of violations has EDINBURGH GENETICS LTD received?
EDINBURGH GENETICS 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 EDINBURGH GENETICS LTD come from?
All FDA import refusal data for EDINBURGH GENETICS 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.