TAKARA BELMONT CORPORATION
⚠️ Moderate Risk
FEI: 3002808310 • Osaka, Osaka • JAPAN
FEI Number
3002808310
Location
Osaka, Osaka
Country
JAPANAddress
2 Chome 1-1, Higashishinsaibashi; Chuo, Osaka, Osaka, 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).
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 |
|---|---|---|---|
| 10/17/2012 | 76EIAUNIT, OPERATIVE DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/17/2012 | 76EIAUNIT, OPERATIVE DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/17/2012 | 76EIAUNIT, OPERATIVE DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/17/2012 | 76EIAUNIT, OPERATIVE DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/17/2012 | 76EIAUNIT, OPERATIVE DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/10/2008 | 76KLCCHAIR WITH UNIT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/8/2006 | 76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER | Florida District Office (FLA-DO) | |
| 11/8/2006 | 76KLCCHAIR WITH UNIT | Florida District Office (FLA-DO) | |
| 7/14/2006 | 80LGXTABLE, EXAMINATION, MEDICAL, POWERED | Los Angeles District Office (LOS-DO) | |
| 6/1/2004 | 80LGXTABLE, EXAMINATION, MEDICAL, POWERED | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/7/2002 | 90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC | 508NO 510(K) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is TAKARA BELMONT CORPORATION's FDA import refusal history?
TAKARA BELMONT CORPORATION (FEI: 3002808310) has 11 FDA import refusal record(s) in our database, spanning from 2/7/2002 to 10/17/2012.
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. TAKARA BELMONT CORPORATION's FEI number is 3002808310.
What types of violations has TAKARA BELMONT CORPORATION received?
TAKARA BELMONT CORPORATION has been cited for 3 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 TAKARA BELMONT CORPORATION come from?
All FDA import refusal data for TAKARA BELMONT 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.