Hamamoto Tech
✅ Low Risk
FEI: 3005887026 • Fukui • JAPAN
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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).
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 |
|---|---|---|---|
| 4/26/2017 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 4/26/2017 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 7/3/2013 | 86HQZFRAME, SPECTACLE | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 7/3/2013 | 86HQZFRAME, SPECTACLE | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hamamoto Tech's FDA import refusal history?
Hamamoto Tech (FEI: 3005887026) has 4 FDA import refusal record(s) in our database, spanning from 7/3/2013 to 4/26/2017.
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. Hamamoto Tech's FEI number is 3005887026.
What types of violations has Hamamoto Tech received?
Hamamoto Tech 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 Hamamoto Tech come from?
All FDA import refusal data for Hamamoto Tech 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.