Tomey Corporation
⚠️ High Risk
FEI: 3002680900 • Nagoya, Aichi • JAPAN
FEI Number
3002680900
Location
Nagoya, Aichi
Country
JAPANAddress
2chome 11-33 Nishi, Noritakeshin-Machi; Nishi; Nishi, Nagoya, Aichi, Japan
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
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).
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.
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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2018 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | Division of Southeast Imports (DSEI) | |
| 3/30/2017 | 86NQEMICROSCOPE, SPECULAR | Division of Southeast Imports (DSEI) | |
| 11/17/2011 | 86NQEMICROSCOPE, SPECULAR | Florida District Office (FLA-DO) | |
| 11/17/2011 | 86NFIDEVICE, HARDCOPY, IMAGES, OPHTHALMIC | Florida District Office (FLA-DO) | |
| 11/17/2011 | 86MMQTOPOGRAPHER, CORNEAL | Florida District Office (FLA-DO) | |
| 11/17/2011 | 86MMQTOPOGRAPHER, CORNEAL | Florida District Office (FLA-DO) | |
| 8/25/2011 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/15/2011 | 86NFIDEVICE, HARDCOPY, IMAGES, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 8/15/2011 | 86NFIDEVICE, HARDCOPY, IMAGES, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 8/15/2011 | 86NFIDEVICE, HARDCOPY, IMAGES, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 8/15/2011 | 86NQEMICROSCOPE, SPECULAR | Division of Southeast Imports (DSEI) | |
| 8/15/2011 | 86MMQTOPOGRAPHER, CORNEAL | Division of Southeast Imports (DSEI) | |
| 7/18/2011 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/18/2011 | 86NQEMICROSCOPE, SPECULAR | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/15/2011 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/15/2011 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/15/2011 | 86NQEMICROSCOPE, SPECULAR | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/12/2011 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 4/12/2011 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 4/12/2011 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 4/12/2011 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 4/12/2011 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 4/12/2011 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 4/6/2011 | 86HKXTONOMETER, AC-POWERED | 508NO 510(K) | Florida District Office (FLA-DO) |
| 4/6/2011 | 86MMQTOPOGRAPHER, CORNEAL | 508NO 510(K) | Florida District Office (FLA-DO) |
| 4/6/2011 | 86NFIDEVICE, HARDCOPY, IMAGES, OPHTHALMIC | 508NO 510(K) | Florida District Office (FLA-DO) |
| 4/6/2011 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 508NO 510(K) | Florida District Office (FLA-DO) |
| 4/6/2011 | 86NQEMICROSCOPE, SPECULAR | 508NO 510(K) | Florida District Office (FLA-DO) |
| 4/6/2011 | 86MMQTOPOGRAPHER, CORNEAL | 508NO 510(K) | Florida District Office (FLA-DO) |
| 1/26/2011 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/26/2011 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/9/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 9/9/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 9/9/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 9/9/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 9/9/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 9/9/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 9/9/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 9/9/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 6/28/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 6/28/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 5/14/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/14/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/14/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/14/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/12/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 4/9/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 4/9/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 2/25/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/25/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/25/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/25/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/25/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/25/2010 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/14/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 9/14/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 9/14/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 9/14/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 9/14/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 8/27/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/8/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 7/8/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 7/8/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 7/8/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 7/8/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 7/8/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 7/8/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 7/8/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 6/24/2009 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | Florida District Office (FLA-DO) | |
| 6/24/2009 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | Florida District Office (FLA-DO) | |
| 6/24/2009 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | Florida District Office (FLA-DO) | |
| 6/24/2009 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | Florida District Office (FLA-DO) | |
| 6/24/2009 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | Florida District Office (FLA-DO) | |
| 5/28/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 5/28/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 5/28/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 5/28/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Florida District Office (FLA-DO) | |
| 3/19/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 3/19/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 3/19/2009 | 86HKYTONOMETER, MANUAL | Division of Southeast Imports (DSEI) | |
| 3/19/2009 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 1/9/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 1/9/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 1/9/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 1/9/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 1/9/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 1/9/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 1/9/2009 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 11/6/2008 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 11/6/2008 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | Division of Southeast Imports (DSEI) | |
| 11/6/2008 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 10/22/2008 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/22/2008 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/22/2008 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/22/2008 | 86MMQTOPOGRAPHER, CORNEAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/20/2008 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/20/2008 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/20/2008 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/20/2008 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/20/2008 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Tomey Corporation's FDA import refusal history?
Tomey Corporation (FEI: 3002680900) has 156 FDA import refusal record(s) in our database, spanning from 7/16/2003 to 5/24/2018.
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. Tomey Corporation's FEI number is 3002680900.
What types of violations has Tomey Corporation received?
Tomey Corporation 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 Tomey Corporation come from?
All FDA import refusal data for Tomey 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.