Melrose Kiwi Concept Chairs
⚠️ Moderate Risk
FEI: 3003077107 • Christchurch • NEW ZEALAND
FEI Number
3003077107
Location
Christchurch
Country
NEW ZEALANDAddress
Po Box 35059 Shorley, , Christchurch, , New Zealand
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).
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.
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 |
|---|---|---|---|
| 3/20/2015 | 89KNOACCESSORIES, WHEELCHAIR | New Orleans District Office (NOL-DO) | |
| 3/20/2015 | 89IMPCUSHION, WHEELCHAIR | New Orleans District Office (NOL-DO) | |
| 3/20/2015 | 89KNOACCESSORIES, WHEELCHAIR | New Orleans District Office (NOL-DO) | |
| 3/20/2015 | 89KNOACCESSORIES, WHEELCHAIR | New Orleans District Office (NOL-DO) | |
| 3/20/2015 | 89KNNCOMPONENTS, WHEELCHAIR | New Orleans District Office (NOL-DO) | |
| 3/20/2015 | 89KNNCOMPONENTS, WHEELCHAIR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Melrose Kiwi Concept Chairs's FDA import refusal history?
Melrose Kiwi Concept Chairs (FEI: 3003077107) has 6 FDA import refusal record(s) in our database, spanning from 3/20/2015 to 3/20/2015.
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. Melrose Kiwi Concept Chairs's FEI number is 3003077107.
What types of violations has Melrose Kiwi Concept Chairs received?
Melrose Kiwi Concept Chairs 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 Melrose Kiwi Concept Chairs come from?
All FDA import refusal data for Melrose Kiwi Concept Chairs 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.