JAPAN AIR SELF-DEFENSE FORCE, MISAWA AIR BASE
⚠️ Moderate Risk
FEI: 3014368497 • Misawa, Aomori • JAPAN
FEI Number
3014368497
Location
Misawa, Aomori
Country
JAPANAddress
Kokuujieitai Misawakichi, Azaushirokubo 125-7 Aza Ushirokubo Ooaza Misawa; Oazamisawa, Misawa, Aomori, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2018 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of Southeast Imports (DSEI) | |
| 4/26/2018 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | Division of Southeast Imports (DSEI) | |
| 4/26/2018 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is JAPAN AIR SELF-DEFENSE FORCE, MISAWA AIR BASE's FDA import refusal history?
JAPAN AIR SELF-DEFENSE FORCE, MISAWA AIR BASE (FEI: 3014368497) has 3 FDA import refusal record(s) in our database, spanning from 4/26/2018 to 4/26/2018.
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. JAPAN AIR SELF-DEFENSE FORCE, MISAWA AIR BASE's FEI number is 3014368497.
What types of violations has JAPAN AIR SELF-DEFENSE FORCE, MISAWA AIR BASE received?
JAPAN AIR SELF-DEFENSE FORCE, MISAWA AIR BASE 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 JAPAN AIR SELF-DEFENSE FORCE, MISAWA AIR BASE come from?
All FDA import refusal data for JAPAN AIR SELF-DEFENSE FORCE, MISAWA AIR BASE 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.