Hitachi High-Technologies Corp.
⚠️ Moderate Risk
FEI: 3003451543 • Tokyo • JAPAN
FEI Number
3003451543
Location
Tokyo
Country
JAPANAddress
24-14 Nishi-Shimbashi 1-Chome, 105-8717, 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
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
Frequently Asked Questions
What is Hitachi High-Technologies Corp.'s FDA import refusal history?
Hitachi High-Technologies Corp. (FEI: 3003451543) has 2 FDA import refusal record(s) in our database, spanning from 8/19/2003 to 4/17/2006.
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 High-Technologies Corp.'s FEI number is 3003451543.
What types of violations has Hitachi High-Technologies Corp. received?
Hitachi High-Technologies Corp. 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 Hitachi High-Technologies Corp. come from?
All FDA import refusal data for Hitachi High-Technologies Corp. 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.