Seiki, Inc.
⚠️ High Risk
FEI: 3003688509 • Kagoshima-shi, Kagoshima • JAPAN
FEI Number
3003688509
Location
Kagoshima-shi, Kagoshima
Country
JAPANAddress
7922-3 Kiire Maenohama-cho, , Kagoshima-shi, Kagoshima, Japan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
MFRHACCP
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
VETDRUGRES
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
HISTAMINE
The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
IMPTRHACCP
The food appears to have been prepared, packed or held under insanitary conditions, or may have become injurious to health, due to the failure of the importer to provide verification of compliance pursuant to 21 CFR 123.12(d).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/10/2025 | 16XVT99AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, N.E.C., | 2860VETDRUGRES | Division of Northeast Imports (DNEI) |
| 2/5/2025 | 16AGD79YELLOWTAIL, AMBERJACK | 2860VETDRUGRES | Division of Northeast Imports (DNEI) |
| 2/5/2025 | 16AGD79YELLOWTAIL, AMBERJACK | 2860VETDRUGRES | Division of Northeast Imports (DNEI) |
| 8/6/2024 | 16XVT99AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, N.E.C., | 2860VETDRUGRES | Division of Northeast Imports (DNEI) |
| 8/6/2024 | 16AVC99FISH, N.E.C. | 2860VETDRUGRES | Division of Northeast Imports (DNEI) |
| 12/12/2017 | 16XVC99AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, N.E.C., | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 12/5/2017 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 11/21/2017 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 11/21/2017 | 16AVD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 11/16/2017 | 16AVC79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 11/16/2017 | 16AVC79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 7/8/2013 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Los Angeles District Office (LOS-DO) |
| 7/8/2013 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Los Angeles District Office (LOS-DO) |
| 7/8/2013 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Los Angeles District Office (LOS-DO) |
| 7/8/2013 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Los Angeles District Office (LOS-DO) |
| 3/12/2013 | 16AGY79YELLOWTAIL, AMBERJACK | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 12/8/2006 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | New York District Office (NYK-DO) |
| 12/8/2006 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | New York District Office (NYK-DO) |
| 12/8/2006 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | New York District Office (NYK-DO) |
| 8/7/2006 | 16AGC79YELLOWTAIL, AMBERJACK | Los Angeles District Office (LOS-DO) | |
| 8/7/2006 | 16AGC79YELLOWTAIL, AMBERJACK | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Seiki, Inc.'s FDA import refusal history?
Seiki, Inc. (FEI: 3003688509) has 21 FDA import refusal record(s) in our database, spanning from 8/7/2006 to 2/10/2025.
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. Seiki, Inc.'s FEI number is 3003688509.
What types of violations has Seiki, Inc. received?
Seiki, Inc. has been cited for 6 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 Seiki, Inc. come from?
All FDA import refusal data for Seiki, Inc. 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.