Shirakawa Olympus Co., Ltd.
⚠️ Moderate Risk
FEI: 3002808148 • Nishishirakawa-Gun, Fukushima • JAPAN
FEI Number
3002808148
Location
Nishishirakawa-Gun, Fukushima
Country
JAPANAddress
Azaokamiyama 3-1, Oazaodakura; Nishigo-Mura, Nishishirakawa-Gun, Fukushima, 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
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.
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 |
|---|---|---|---|
| 10/23/2018 | 78FETTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE | 2780DEVICEGMPS | Division of Northeast Imports (DNEI) |
| 10/23/2018 | 78FETTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE | 2780DEVICEGMPS | Division of Northeast Imports (DNEI) |
| 4/20/2016 | 78NWBENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/9/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Shirakawa Olympus Co., Ltd.'s FDA import refusal history?
Shirakawa Olympus Co., Ltd. (FEI: 3002808148) has 4 FDA import refusal record(s) in our database, spanning from 12/9/2015 to 10/23/2018.
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. Shirakawa Olympus Co., Ltd.'s FEI number is 3002808148.
What types of violations has Shirakawa Olympus Co., Ltd. received?
Shirakawa Olympus Co., 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 Shirakawa Olympus Co., Ltd. come from?
All FDA import refusal data for Shirakawa Olympus 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.