Ebisu Kk
✅ Low Risk
FEI: 3002997886 • Yamatokoriyama Nara • JAPAN
FEI Number
3002997886
Location
Yamatokoriyama Nara
Country
JAPANAddress
321 Nishimachi, , Yamatokoriyama Nara, , 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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/8/2019 | 76EFWTOOTHBRUSH, MANUAL | Division of Northern Border Imports (DNBI) | |
| 6/22/2018 | 76EFWTOOTHBRUSH, MANUAL | Division of Northern Border Imports (DNBI) | |
| 12/13/2001 | 53IY99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Ebisu Kk's FDA import refusal history?
Ebisu Kk (FEI: 3002997886) has 3 FDA import refusal record(s) in our database, spanning from 12/13/2001 to 4/8/2019.
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. Ebisu Kk's FEI number is 3002997886.
What types of violations has Ebisu Kk received?
Ebisu Kk 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 Ebisu Kk come from?
All FDA import refusal data for Ebisu Kk 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.