NIPRO INDIA CORPORATION PVT.LTD.
⚠️ Moderate Risk
FEI: 3041232441 • Khandala, Maharashtra • INDIA
FEI Number
3041232441
Location
Khandala, Maharashtra
Country
INDIAAddress
Mh - 412802 Plot No E - 1, Dist - Satara; 1 Industrail Area, Khandala, Maharashtra, India
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2025 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NIPRO INDIA CORPORATION PVT.LTD.'s FDA import refusal history?
NIPRO INDIA CORPORATION PVT.LTD. (FEI: 3041232441) has 1 FDA import refusal record(s) in our database, spanning from 12/11/2025 to 12/11/2025.
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 INDIA CORPORATION PVT.LTD.'s FEI number is 3041232441.
What types of violations has NIPRO INDIA CORPORATION PVT.LTD. received?
NIPRO INDIA CORPORATION PVT.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 NIPRO INDIA CORPORATION PVT.LTD. come from?
All FDA import refusal data for NIPRO INDIA CORPORATION PVT.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.