Shiga Factory Bayer Yakuchin Ltd
⚠️ Moderate Risk
FEI: 3003522192 • Koka Gun, Shiga • JAPAN
FEI Number
3003522192
Location
Koka Gun, Shiga
Country
JAPANAddress
1211, Toriino; Koko Cho, Koka Gun, Shiga, 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).
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 |
|---|---|---|---|
| 5/16/2003 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | New York District Office (NYK-DO) | |
| 5/16/2003 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | New York District Office (NYK-DO) | |
| 5/16/2003 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | New York District Office (NYK-DO) | |
| 5/16/2003 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Shiga Factory Bayer Yakuchin Ltd's FDA import refusal history?
Shiga Factory Bayer Yakuchin Ltd (FEI: 3003522192) has 4 FDA import refusal record(s) in our database, spanning from 5/16/2003 to 5/16/2003.
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. Shiga Factory Bayer Yakuchin Ltd's FEI number is 3003522192.
What types of violations has Shiga Factory Bayer Yakuchin Ltd received?
Shiga Factory Bayer Yakuchin Ltd has been cited for 2 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 Shiga Factory Bayer Yakuchin Ltd come from?
All FDA import refusal data for Shiga Factory Bayer Yakuchin 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.