Randox Labs Ltd
⚠️ Moderate Risk
FEI: 3008890072 • Belfast • UNITED KINGDOM
FEI Number
3008890072
Location
Belfast
Country
UNITED KINGDOMAddress
55 The Diamonds Road, , Belfast, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
Frequently Asked Questions
What is Randox Labs Ltd's FDA import refusal history?
Randox Labs Ltd (FEI: 3008890072) has 2 FDA import refusal record(s) in our database, spanning from 3/4/2024 to 3/4/2024.
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. Randox Labs Ltd's FEI number is 3008890072.
What types of violations has Randox Labs Ltd received?
Randox Labs 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 Randox Labs Ltd come from?
All FDA import refusal data for Randox Labs 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.