POLY MEDICURE LTD
⚠️ High Risk
FEI: 3003205539 • Faridabad, Haryana • INDIA
FEI Number
3003205539
Location
Faridabad, Haryana
Country
INDIAAddress
Plot No. 115, 116 & 117, Sector 59, HSIIDC Industrial Area, Ballabgarh, Faridabad, Haryana, 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).
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.
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 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/19/2024 | 79GBXCATHETER, IRRIGATION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2006 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Florida District Office (FLA-DO) | |
| 3/17/2004 | 80FPKTUBING, FLUID DELIVERY | Florida District Office (FLA-DO) | |
| 3/17/2004 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Florida District Office (FLA-DO) | |
| 3/17/2004 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | Florida District Office (FLA-DO) | |
| 3/17/2004 | 80KZDINFUSOR, PRESSURE, FOR I.V. BAGS | Florida District Office (FLA-DO) | |
| 3/17/2004 | 77KCPSYRINGE, ENT | Florida District Office (FLA-DO) | |
| 3/17/2004 | 80BRZSET, BLOOD TRANSFUSION | Florida District Office (FLA-DO) | |
| 3/17/2004 | 80MRZACCESSORIES, PUMP, INFUSION | Florida District Office (FLA-DO) | |
| 1/5/2004 | 77ETLNASAL FLOWMETER, | 237NO PMA | Florida District Office (FLA-DO) |
| 1/5/2004 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 237NO PMA | Florida District Office (FLA-DO) |
| 1/5/2004 | 80KZDINFUSOR, PRESSURE, FOR I.V. BAGS | 237NO PMA | Florida District Office (FLA-DO) |
| 1/5/2004 | 80FMGSTOPCOCK, I.V. SET | 237NO PMA | Florida District Office (FLA-DO) |
| 1/5/2004 | 80MRZACCESSORIES, PUMP, INFUSION | 237NO PMA | Florida District Office (FLA-DO) |
| 1/5/2004 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | 237NO PMA | Florida District Office (FLA-DO) |
| 1/5/2004 | 80BRZSET, BLOOD TRANSFUSION | 237NO PMA | Florida District Office (FLA-DO) |
| 1/5/2004 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 237NO PMA | Florida District Office (FLA-DO) |
| 7/25/2003 | 80KZDINFUSOR, PRESSURE, FOR I.V. BAGS | Florida District Office (FLA-DO) | |
| 7/25/2003 | 80FMGSTOPCOCK, I.V. SET | Florida District Office (FLA-DO) | |
| 7/25/2003 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | Florida District Office (FLA-DO) | |
| 7/25/2003 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | Florida District Office (FLA-DO) | |
| 7/25/2003 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Florida District Office (FLA-DO) | |
| 7/25/2003 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | Florida District Office (FLA-DO) | |
| 7/25/2003 | 80BRZSET, BLOOD TRANSFUSION | Florida District Office (FLA-DO) | |
| 7/25/2003 | 80LHISET, I.V. FLUID TRANSER | Florida District Office (FLA-DO) | |
| 5/20/2003 | 79LRSI.V. START KIT | Florida District Office (FLA-DO) | |
| 5/20/2003 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/25/2002 | 78EZDCATHETER, STRAIGHT | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/6/2002 | 80JOLCATHETER AND TIP, SUCTION | Florida District Office (FLA-DO) | |
| 3/6/2002 | 80LHISET, I.V. FLUID TRANSER | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is POLY MEDICURE LTD's FDA import refusal history?
POLY MEDICURE LTD (FEI: 3003205539) has 30 FDA import refusal record(s) in our database, spanning from 3/6/2002 to 3/19/2024.
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. POLY MEDICURE LTD's FEI number is 3003205539.
What types of violations has POLY MEDICURE LTD received?
POLY MEDICURE LTD has been cited for 4 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 POLY MEDICURE LTD come from?
All FDA import refusal data for POLY MEDICURE 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.