MANDELAY KFT
⚠️ Moderate Risk
FEI: 3010452718 • Tokol, Pest • HUNGARY
FEI Number
3010452718
Location
Tokol, Pest
Country
HUNGARYAddress
Huba Utca 25-2, , Tokol, Pest, Hungary
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2022 | 73BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 2/1/2022 | 73BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 8/30/2018 | 84HCCDEVICE, BIOFEEDBACK | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/30/2018 | 84HCCDEVICE, BIOFEEDBACK | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/14/2017 | 84HCCDEVICE, BIOFEEDBACK | Division of Southeast Imports (DSEI) | |
| 8/10/2012 | 84HCCDEVICE, BIOFEEDBACK | 223FALSE | New Orleans District Office (NOL-DO) |
| 1/11/2008 | 84HCCDEVICE, BIOFEEDBACK | New Orleans District Office (NOL-DO) | |
| 8/24/2004 | 54ACA99VITAMIN, N.E.C. | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 4/13/2004 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/12/2004 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/30/2004 | 84HCCDEVICE, BIOFEEDBACK | Seattle District Office (SEA-DO) | |
| 2/4/2004 | 79FSPLOUPE, DIAGNOSTIC/SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/22/2003 | 84GWLAMPLIFIER, PHYSIOLOGICAL SIGNAL | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is MANDELAY KFT's FDA import refusal history?
MANDELAY KFT (FEI: 3010452718) has 13 FDA import refusal record(s) in our database, spanning from 12/22/2003 to 2/1/2022.
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. MANDELAY KFT's FEI number is 3010452718.
What types of violations has MANDELAY KFT received?
MANDELAY KFT has been cited for 8 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 MANDELAY KFT come from?
All FDA import refusal data for MANDELAY KFT 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.