SPM MEDICARE PVT. LTD
⚠️ High Risk
FEI: 3016707060 • Noida, Uttar Pradesh • INDIA
FEI Number
3016707060
Location
Noida, Uttar Pradesh
Country
INDIAAddress
B-40, PHASE-II, GAUTAM BUDDHA NAGAR, Unit I- B 40, Phase II, District: Gautam Buddha Nagar, Noida, Uttar Pradesh, 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2025 | 80NGTDEVICE, FLUSH, VASCULAR ACCESS | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 8/16/2024 | 80FMFSYRINGE, PISTON | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 80FMFSYRINGE, PISTON | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 73CBTKIT, SAMPLING, ARTERIAL BLOOD | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 73CBTKIT, SAMPLING, ARTERIAL BLOOD | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 73CBTKIT, SAMPLING, ARTERIAL BLOOD | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 80NGTDEVICE, FLUSH, VASCULAR ACCESS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 80NGTDEVICE, FLUSH, VASCULAR ACCESS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 80NGTDEVICE, FLUSH, VASCULAR ACCESS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 80NGTDEVICE, FLUSH, VASCULAR ACCESS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 80NGTDEVICE, FLUSH, VASCULAR ACCESS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 80NGTDEVICE, FLUSH, VASCULAR ACCESS | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SPM MEDICARE PVT. LTD's FDA import refusal history?
SPM MEDICARE PVT. LTD (FEI: 3016707060) has 12 FDA import refusal record(s) in our database, spanning from 8/16/2024 to 12/23/2025.
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. SPM MEDICARE PVT. LTD's FEI number is 3016707060.
What types of violations has SPM MEDICARE PVT. LTD received?
SPM MEDICARE 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 SPM MEDICARE PVT. LTD come from?
All FDA import refusal data for SPM MEDICARE 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.