ASAHI POLYSLIDER CO.,LTD
⚠️ Moderate Risk
FEI: 3012391968 • Osaka, Osaka • JAPAN
FEI Number
3012391968
Location
Osaka, Osaka
Country
JAPANAddress
Nakanoshima Mitsui Building, Nakanoshima; Kita, Osaka, Osaka, Japan
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2024 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of Southeast Imports (DSEI) | |
| 1/11/2022 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/3/2021 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/19/2021 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/12/2017 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/3/2017 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of Southeast Imports (DSEI) | |
| 6/14/2016 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of Southeast Imports (DSEI) | |
| 5/13/2016 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/9/2016 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of Southeast Imports (DSEI) | |
| 11/24/2015 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/23/2015 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of Southeast Imports (DSEI) | |
| 7/17/2015 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/23/2015 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ASAHI POLYSLIDER CO.,LTD's FDA import refusal history?
ASAHI POLYSLIDER CO.,LTD (FEI: 3012391968) has 13 FDA import refusal record(s) in our database, spanning from 6/23/2015 to 1/22/2024.
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. ASAHI POLYSLIDER CO.,LTD's FEI number is 3012391968.
What types of violations has ASAHI POLYSLIDER CO.,LTD received?
ASAHI POLYSLIDER CO.,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 ASAHI POLYSLIDER CO.,LTD come from?
All FDA import refusal data for ASAHI POLYSLIDER 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.