RDT
⚠️ Moderate Risk
FEI: 3013754757 • Basingstoke • UNITED KINGDOM
FEI Number
3013754757
Location
Basingstoke
Country
UNITED KINGDOMAddress
Pavillion C2, , Basingstoke, , 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/12/2018 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/12/2018 | 74DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/6/2018 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 7/6/2018 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is RDT's FDA import refusal history?
RDT (FEI: 3013754757) has 4 FDA import refusal record(s) in our database, spanning from 7/6/2018 to 7/12/2018.
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. RDT's FEI number is 3013754757.
What types of violations has RDT received?
RDT 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 RDT come from?
All FDA import refusal data for RDT 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.