Nipro India Co Pvt Ltd
⚠️ Moderate Risk
FEI: 3009346101 • Chennai • INDIA
FEI Number
3009346101
Location
Chennai
Country
INDIAAddress
167 Yesdee House Valluvarkottam, , Chennai, , 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/21/2023 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/21/2022 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/29/2021 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/17/2021 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/16/2020 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Nipro India Co Pvt Ltd's FDA import refusal history?
Nipro India Co Pvt Ltd (FEI: 3009346101) has 5 FDA import refusal record(s) in our database, spanning from 5/16/2020 to 2/21/2023.
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 Co Pvt Ltd's FEI number is 3009346101.
What types of violations has Nipro India Co Pvt Ltd received?
Nipro India Co Pvt Ltd 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 India Co Pvt Ltd come from?
All FDA import refusal data for Nipro India Co 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.