Tanaka Production Co., Ltd.
✅ Low Risk
FEI: 3006688220 • Sabae, Fukui • JAPAN
FEI Number
3006688220
Location
Sabae, Fukui
Country
JAPANAddress
4 Chome 15-4, Higashisabae, Sabae, Fukui, Japan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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 |
|---|---|---|---|
| 9/5/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Tanaka Production Co., Ltd.'s FDA import refusal history?
Tanaka Production Co., Ltd. (FEI: 3006688220) has 1 FDA import refusal record(s) in our database, spanning from 9/5/2020 to 9/5/2020.
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. Tanaka Production Co., Ltd.'s FEI number is 3006688220.
What types of violations has Tanaka Production Co., Ltd. received?
Tanaka Production 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 Tanaka Production Co., Ltd. come from?
All FDA import refusal data for Tanaka Production 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.