Kitamura Trade Services Co.,Ltd.
✅ Low Risk
FEI: 3008372762 • Sawa-Gun, Gunma • JAPAN
FEI Number
3008372762
Location
Sawa-Gun, Gunma
Country
JAPANAddress
4-Chome 2-10, Tamamura-Machi, Sawa-Gun, Gunma, 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
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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
Frequently Asked Questions
What is Kitamura Trade Services Co.,Ltd.'s FDA import refusal history?
Kitamura Trade Services Co.,Ltd. (FEI: 3008372762) has 1 FDA import refusal record(s) in our database, spanning from 9/8/2010 to 9/8/2010.
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. Kitamura Trade Services Co.,Ltd.'s FEI number is 3008372762.
What types of violations has Kitamura Trade Services Co.,Ltd. received?
Kitamura Trade Services Co.,Ltd. has been cited for 3 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 Kitamura Trade Services Co.,Ltd. come from?
All FDA import refusal data for Kitamura Trade Services 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.