Huntleigh Healthcare Ltd.
⚠️ Moderate Risk
FEI: 1000589001 • Cardiff, CRF • UNITED KINGDOM
FEI Number
1000589001
Location
Cardiff, CRF
Country
UNITED KINGDOMAddress
35 Portmanmoor Road Industrial Estate, South, Cardiff, CRF, 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
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2020 | 85HGLTRANSDUCER, ULTRASONIC, OBSTETRIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/23/2015 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/28/2015 | 80LDQDEVICE, GENERAL MEDICAL | Florida District Office (FLA-DO) | |
| 7/28/2015 | 80LDQDEVICE, GENERAL MEDICAL | Florida District Office (FLA-DO) | |
| 7/28/2015 | 80LDQDEVICE, GENERAL MEDICAL | Florida District Office (FLA-DO) | |
| 7/28/2015 | 85KNGMONITOR, ULTRASONIC, FETAL | Florida District Office (FLA-DO) | |
| 7/28/2015 | 74KRIACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Huntleigh Healthcare Ltd.'s FDA import refusal history?
Huntleigh Healthcare Ltd. (FEI: 1000589001) has 7 FDA import refusal record(s) in our database, spanning from 7/28/2015 to 9/2/2020.
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. Huntleigh Healthcare Ltd.'s FEI number is 1000589001.
What types of violations has Huntleigh Healthcare Ltd. received?
Huntleigh Healthcare Ltd. has been cited for 3 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 Huntleigh Healthcare Ltd. come from?
All FDA import refusal data for Huntleigh Healthcare 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.