Tohoku Pioneer Electronic Corp.
⚠️ Moderate Risk
FEI: 1000392704 • Tendo City, Yamagata • JAPAN
FEI Number
1000392704
Location
Tendo City, Yamagata
Country
JAPANAddress
1105 Kunomoto, Tendo City, , Tendo City, Yamagata, 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/12/2009 | 79FXXMASK, SURGICAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/24/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Chicago District Office (CHI-DO) |
| 8/22/2003 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Chicago District Office (CHI-DO) |
| 6/18/2003 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Chicago District Office (CHI-DO) |
| 4/15/2002 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Tohoku Pioneer Electronic Corp.'s FDA import refusal history?
Tohoku Pioneer Electronic Corp. (FEI: 1000392704) has 5 FDA import refusal record(s) in our database, spanning from 4/15/2002 to 6/12/2009.
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. Tohoku Pioneer Electronic Corp.'s FEI number is 1000392704.
What types of violations has Tohoku Pioneer Electronic Corp. received?
Tohoku Pioneer Electronic 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 Tohoku Pioneer Electronic Corp. come from?
All FDA import refusal data for Tohoku Pioneer Electronic 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.