Mangar International Ltd
⚠️ Moderate Risk
FEI: 3011134182 • Birminghambirmingham • UNITED KINGDOM
FEI Number
3011134182
Location
Birminghambirmingham
Country
UNITED KINGDOMAddress
Presteigne Powys, , Birminghambirmingham, , 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).
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 |
|---|---|---|---|
| 12/3/2014 | 80FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | Cincinnati District Office (CIN-DO) | |
| 12/3/2014 | 89INNCHAIR, ADJUSTABLE, MECHANICAL | Cincinnati District Office (CIN-DO) | |
| 12/3/2014 | 89INNCHAIR, ADJUSTABLE, MECHANICAL | Cincinnati District Office (CIN-DO) | |
| 12/3/2014 | 80FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Mangar International Ltd's FDA import refusal history?
Mangar International Ltd (FEI: 3011134182) has 4 FDA import refusal record(s) in our database, spanning from 12/3/2014 to 12/3/2014.
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. Mangar International Ltd's FEI number is 3011134182.
What types of violations has Mangar International Ltd received?
Mangar International 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 Mangar International Ltd come from?
All FDA import refusal data for Mangar International 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.