STERIMED SURGICALS (INDIA) PVT
⚠️ High Risk
FEI: 3016604046 • New Delhi • INDIA
FEI
FEI Number
3016604046
📍
Location
New Delhi
🇮🇳
Country
INDIA🏢
Address
Unit No 501 Ring Rd Mal, , New Delhi, , India
High Risk
FDA Import Risk Assessment
66.3
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
115
Total Refusals
3
Unique Violations
5/13/2024
Latest Refusal
3/22/2024
Earliest Refusal
Score Breakdown
Violation Severity
50.1×40%
Refusal Volume
76.5×30%
Recency
66.8×20%
Frequency
100.0×10%
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
118115×
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).
3280115×
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.
5081×
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 |
|---|---|---|---|
| 5/13/2024 | 80JOLCATHETER AND TIP, SUCTION | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GBACATHETER, BALLOON TYPE | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73PHSORAL AIRWAY ASSIST | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73PHSORAL AIRWAY ASSIST | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73PHSORAL AIRWAY ASSIST | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73PHSORAL AIRWAY ASSIST | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73PHSORAL AIRWAY ASSIST | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73PHSORAL AIRWAY ASSIST | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73PHSORAL AIRWAY ASSIST | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73PHSORAL AIRWAY ASSIST | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 78PRRFEEDING TUBE KIT | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 78PRRFEEDING TUBE KIT | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 78PRRFEEDING TUBE KIT | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 78PRRFEEDING TUBE KIT | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 78GBTCATHETER, RECTAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 78GBTCATHETER, RECTAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 79GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 80QGIAIR-HANDLING APPARATUS ACCESSORY | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 80QGIAIR-HANDLING APPARATUS ACCESSORY | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 73LNZCHANGER, TUBE, ENDOTRACHEAL | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 80QGIAIR-HANDLING APPARATUS ACCESSORY | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 80QGIAIR-HANDLING APPARATUS ACCESSORY | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 80QGIAIR-HANDLING APPARATUS ACCESSORY | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 80QGIAIR-HANDLING APPARATUS ACCESSORY | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 80QGIAIR-HANDLING APPARATUS ACCESSORY | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 80QGIAIR-HANDLING APPARATUS ACCESSORY | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 80QGIAIR-HANDLING APPARATUS ACCESSORY | Division of Southeast Imports (DSEI) | |
| 3/22/2024 | 80QGIAIR-HANDLING APPARATUS ACCESSORY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is STERIMED SURGICALS (INDIA) PVT's FDA import refusal history?
STERIMED SURGICALS (INDIA) PVT (FEI: 3016604046) has 115 FDA import refusal record(s) in our database, spanning from 3/22/2024 to 5/13/2024.
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. STERIMED SURGICALS (INDIA) PVT's FEI number is 3016604046.
What types of violations has STERIMED SURGICALS (INDIA) PVT received?
STERIMED SURGICALS (INDIA) PVT has been cited for 3 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 STERIMED SURGICALS (INDIA) PVT come from?
All FDA import refusal data for STERIMED SURGICALS (INDIA) PVT 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.