HITACHI , LTD. HEALTHCARE TOKYO WORKS
⚠️ Moderate Risk
FEI: 3002806350 • Ome, Tokyo • JAPAN
FEI Number
3002806350
Location
Ome, Tokyo
Country
JAPANAddress
Aroka (Kabu) Tokyojigyosho, 3 Chome 7-19; Imai, Ome, Tokyo, 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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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 |
|---|---|---|---|
| 3/3/2020 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of Southeast Imports (DSEI) | |
| 2/26/2008 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 3/3/2006 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is HITACHI , LTD. HEALTHCARE TOKYO WORKS's FDA import refusal history?
HITACHI , LTD. HEALTHCARE TOKYO WORKS (FEI: 3002806350) has 3 FDA import refusal record(s) in our database, spanning from 3/3/2006 to 3/3/2020.
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. HITACHI , LTD. HEALTHCARE TOKYO WORKS's FEI number is 3002806350.
What types of violations has HITACHI , LTD. HEALTHCARE TOKYO WORKS received?
HITACHI , LTD. HEALTHCARE TOKYO WORKS has been cited for 4 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 HITACHI , LTD. HEALTHCARE TOKYO WORKS come from?
All FDA import refusal data for HITACHI , LTD. HEALTHCARE TOKYO WORKS 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.