Yamamoto Kogaku Co.,Ltd.
✅ Low Risk
FEI: 1000629909 • Higashiosaka, Osaka • JAPAN
FEI Number
1000629909
Location
Higashiosaka, Osaka
Country
JAPANAddress
25-8 3, Cho-Do, Higashiosaka, Osaka, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/9/2018 | 90IWQCURTAIN, PROTECTIVE, RADIOGRAPHIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/12/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 1/4/2006 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Yamamoto Kogaku Co.,Ltd.'s FDA import refusal history?
Yamamoto Kogaku Co.,Ltd. (FEI: 1000629909) has 3 FDA import refusal record(s) in our database, spanning from 1/4/2006 to 2/9/2018.
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. Yamamoto Kogaku Co.,Ltd.'s FEI number is 1000629909.
What types of violations has Yamamoto Kogaku Co.,Ltd. received?
Yamamoto Kogaku Co.,Ltd. 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 Yamamoto Kogaku Co.,Ltd. come from?
All FDA import refusal data for Yamamoto Kogaku Co.,Ltd. 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.