ZOOMCO-MEDIC
⚠️ High Risk
FEI: 3027269633 • Prevost, Quebec • CANADA
FEI Number
3027269633
Location
Prevost, Quebec
Country
CANADAAddress
1146 Laberge St, , Prevost, Quebec, Canada
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/26/2024 | 80FMGSTOPCOCK, I.V. SET | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 78FKGTRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FMGSTOPCOCK, I.V. SET | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 79PUIDRAPE, SURGICAL, EXEMPT | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80KXGAPPLICATOR, ABSORBENT TIPPED, STERILE | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 79OJVSINGLE USE INSTRUMENT TRAY KIT | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 79MCZSUTURE REMOVAL KIT | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FMHCONTAINER, SPECIMEN | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 79FRODRESSING, WOUND, DRUG | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 79FRODRESSING, WOUND, DRUG | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 79FRODRESSING, WOUND, DRUG | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FMGSTOPCOCK, I.V. SET | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 79FRODRESSING, WOUND, DRUG | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 90OIPRADIOLOGY DIAGNOSTIC KIT | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80KMJLUBRICANT, PATIENT | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 79FRODRESSING, WOUND, DRUG | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) | |
| 7/23/2024 | 80FPKTUBING, FLUID DELIVERY | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is ZOOMCO-MEDIC's FDA import refusal history?
ZOOMCO-MEDIC (FEI: 3027269633) has 29 FDA import refusal record(s) in our database, spanning from 7/23/2024 to 7/26/2024.
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. ZOOMCO-MEDIC's FEI number is 3027269633.
What types of violations has ZOOMCO-MEDIC received?
ZOOMCO-MEDIC 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 ZOOMCO-MEDIC come from?
All FDA import refusal data for ZOOMCO-MEDIC 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.