NIPRO CORPORATION
⚠️ Moderate Risk
FEI: 3027266136 • Settsu, Osaka • JAPAN
FEI Number
3027266136
Location
Settsu, Osaka
Country
JAPANAddress
3-26 Fu, Senriokashin-Machi, Settsu, Osaka, 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
Frequently Asked Questions
What is NIPRO CORPORATION's FDA import refusal history?
NIPRO CORPORATION (FEI: 3027266136) has 2 FDA import refusal record(s) in our database, spanning from 12/5/2024 to 5/8/2025.
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. NIPRO CORPORATION's FEI number is 3027266136.
What types of violations has NIPRO CORPORATION received?
NIPRO CORPORATION 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 NIPRO CORPORATION come from?
All FDA import refusal data for NIPRO CORPORATION 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.