YAC ELEX CO.,LTD
⚠️ High Risk
FEI: 3016602229 • Higashiosaka, Osaka • JAPAN
FEI Number
3016602229
Location
Higashiosaka, Osaka
Country
JAPANAddress
2 Chome 1-36, Sumida, Higashiosaka, Osaka, Japan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 5/20/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 7/18/2022 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/14/2022 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/14/2022 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2022 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/21/2022 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/29/2021 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/3/2021 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 11/18/2021 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 10/8/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 9/29/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 9/24/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/24/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/24/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/24/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is YAC ELEX CO.,LTD's FDA import refusal history?
YAC ELEX CO.,LTD (FEI: 3016602229) has 18 FDA import refusal record(s) in our database, spanning from 4/24/2020 to 8/27/2024.
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. YAC ELEX CO.,LTD's FEI number is 3016602229.
What types of violations has YAC ELEX CO.,LTD received?
YAC ELEX CO.,LTD has been cited for 5 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 YAC ELEX CO.,LTD come from?
All FDA import refusal data for YAC ELEX CO.,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.