Olympus Corporation of the Americas
⚠️ High Risk
FEI: 2429304 • Center Valley, PA • UNITED STATES
FEI Number
2429304
Location
Center Valley, PA
Country
UNITED STATESAddress
3500 Corporate Pkwy, , Center Valley, PA, United States
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).
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.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/27/2025 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | Division of Southeast Imports (DSEI) | |
| 8/14/2024 | 78FDFCOLONOSCOPE, GASTRO-UROLOGY | Division of Southeast Imports (DSEI) | |
| 3/13/2024 | 78FBNCHOLEDOCHOSCOPE, FLEXIBLE OR RIGID | Division of West Coast Imports (DWCI) | |
| 3/13/2024 | 77EOQBRONCHOSCOPE (FLEXIBLE OR RIGID) | Division of West Coast Imports (DWCI) | |
| 9/21/2022 | 77EOQBRONCHOSCOPE (FLEXIBLE OR RIGID) | Division of Southeast Imports (DSEI) | |
| 11/18/2020 | 78FBNCHOLEDOCHOSCOPE, FLEXIBLE OR RIGID | Division of West Coast Imports (DWCI) | |
| 9/4/2020 | 78FAJCYSTOSCOPE, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/26/2017 | 78FDFCOLONOSCOPE, GASTRO-UROLOGY | Division of Southeast Imports (DSEI) | |
| 4/26/2017 | 90LMBDEVICE, DIGITAL IMAGE STORAGE | Division of Southeast Imports (DSEI) | |
| 9/28/2016 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Cincinnati District Office (CIN-DO) | |
| 8/6/2015 | 78FDFCOLONOSCOPE, GASTRO-UROLOGY | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/18/2015 | 78GCKGASTROSCOPE, GENERAL & PLASTIC SURGERY | New Orleans District Office (NOL-DO) | |
| 6/5/2015 | 94RCMMICROSCOPE (ELECTRON BEAM), NON-MEDICAL INDUSTRIAL PARTICLE BEAM SYSTEMS | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/24/2014 | 78FGBURETEROSCOPE | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 10/24/2013 | 90LLZSYSTEM, IMAGE PROCESSING | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 6/11/2013 | 85HIHHYSTEROSCOPE (AND ACCESSORIES) | New Orleans District Office (NOL-DO) | |
| 1/17/2013 | 78KOGENDOSCOPE AND/OR ACCESSORIES | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/27/2011 | 75JJFANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/18/2007 | 78GCKGASTROSCOPE, GENERAL & PLASTIC SURGERY | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Olympus Corporation of the Americas's FDA import refusal history?
Olympus Corporation of the Americas (FEI: 2429304) has 19 FDA import refusal record(s) in our database, spanning from 4/18/2007 to 5/27/2025.
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 Corporation of the Americas's FEI number is 2429304.
What types of violations has Olympus Corporation of the Americas received?
Olympus Corporation of the Americas 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 Olympus Corporation of the Americas come from?
All FDA import refusal data for Olympus Corporation of the Americas 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.