NARA CO.,LTD.
🚨 Critical Risk
FEI: 3004249809 • Ibusuki, Kagoshima • JAPAN
FEI Number
3004249809
Location
Ibusuki, Kagoshima
Country
JAPANAddress
486-1, NISHIKATA, , Ibusuki, Kagoshima, Japan
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/28/2025 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 12/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 12/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 12/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 12/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 12/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 11/1/2024 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 11/1/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 10/3/2024 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 9/11/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 9/11/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 9/3/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 9/3/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 8/17/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 8/5/2024 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 8/5/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 8/5/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 8/5/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 8/5/2024 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 8/5/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 8/5/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/16/2024 | 16AVT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/5/2024 | 16AGD79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/5/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
| 7/5/2024 | 16AGT79YELLOWTAIL, AMBERJACK | 2580MFRHACCP | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is NARA CO.,LTD.'s FDA import refusal history?
NARA CO.,LTD. (FEI: 3004249809) has 33 FDA import refusal record(s) in our database, spanning from 7/5/2024 to 1/28/2025.
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. NARA CO.,LTD.'s FEI number is 3004249809.
What types of violations has NARA CO.,LTD. received?
NARA CO.,LTD. has been cited for 1 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 NARA CO.,LTD. come from?
All FDA import refusal data for NARA CO.,LTD. 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.