NIPRO INDIA CORPORATION PVT.LTD.
⚠️ High Risk
FEI: 3014045945 • Khandala, Maharashtra • INDIA
FEI Number
3014045945
Location
Khandala, Maharashtra
Country
INDIAAddress
E - 1 Midc Kesurdi, Dist - Satara, Khandala, Maharashtra, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2025 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 10/7/2025 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/11/2025 | 78FJIDIALYZER, CAPILLARY, HOLLOW FIBER | Division of Southeast Imports (DSEI) | |
| 7/23/2025 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/18/2025 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 6/26/2025 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 3/10/2025 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 3/6/2025 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 3/6/2025 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/15/2025 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/26/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 12/3/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/15/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 10/18/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 8/29/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 8/27/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 8/6/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/26/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/9/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/16/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | Division of Southeast Imports (DSEI) | |
| 8/7/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 237NO PMA | Division of Southeast Imports (DSEI) |
| 5/18/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 3280FRNMFGREG | 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: 3014045945) has 22 FDA import refusal record(s) in our database, spanning from 5/18/2020 to 11/20/2025.
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 3014045945.
What types of violations has NIPRO INDIA CORPORATION PVT.LTD. received?
NIPRO INDIA CORPORATION PVT.LTD. has been cited for 6 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.