Olympus Medical Systems Corporation
⚠️ Moderate Risk
FEI: 3002807795 • Hachioji, Tokyo • JAPAN
FEI Number
3002807795
Location
Hachioji, Tokyo
Country
JAPANAddress
Orinpasukogakukogyo (Kabu) Gijutsukaihatsusentaishikawa, 2951; Ishikawa-Machi, Hachioji, Tokyo, 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
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).
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.
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 |
|---|---|---|---|
| 11/2/2023 | 77EOQBRONCHOSCOPE (FLEXIBLE OR RIGID) | Division of West Coast Imports (DWCI) | |
| 11/2/2023 | 78FDFCOLONOSCOPE, GASTRO-UROLOGY | Division of West Coast Imports (DWCI) | |
| 11/2/2023 | 78FDFCOLONOSCOPE, GASTRO-UROLOGY | Division of West Coast Imports (DWCI) | |
| 11/2/2023 | 78FDSGASTROSCOPE, GASTRO-UROLOGY | Division of West Coast Imports (DWCI) | |
| 11/2/2023 | 78FDSGASTROSCOPE, GASTRO-UROLOGY | Division of West Coast Imports (DWCI) | |
| 11/2/2023 | 78FAJCYSTOSCOPE, DIAGNOSTIC | Division of West Coast Imports (DWCI) | |
| 11/2/2023 | 78GDBENDOSCOPE, FIBER OPTIC | Division of West Coast Imports (DWCI) | |
| 11/2/2023 | 78PPENEPHROSCOPE SET | Division of West Coast Imports (DWCI) | |
| 2/4/2022 | 78GCQENDOSCOPE, FLEXIBLE | Division of Southeast Imports (DSEI) | |
| 3/16/2021 | 78FDTDUODEDOSCOPE, ESOPHAGO GASTRO | Division of Southeast Imports (DSEI) | |
| 2/12/2019 | 78NWBENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM | Division of Southeast Imports (DSEI) | |
| 2/6/2019 | 78FBNCHOLEDOCHOSCOPE, FLEXIBLE OR RIGID | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/2/2018 | 77EOQBRONCHOSCOPE (FLEXIBLE OR RIGID) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/11/2017 | 78GCNENDOSCOPE, PRISM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/26/2016 | 78FETTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 10/25/2013 | 78FDFCOLONOSCOPE, GASTRO-UROLOGY | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Olympus Medical Systems Corporation's FDA import refusal history?
Olympus Medical Systems Corporation (FEI: 3002807795) has 16 FDA import refusal record(s) in our database, spanning from 10/25/2013 to 11/2/2023.
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. Olympus Medical Systems Corporation's FEI number is 3002807795.
What types of violations has Olympus Medical Systems Corporation received?
Olympus Medical Systems Corporation has been cited for 4 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 Olympus Medical Systems Corporation come from?
All FDA import refusal data for Olympus Medical Systems Corporation 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.