Amvex Corporation
⚠️ Moderate Risk
FEI: 3003272769 • Richmond Hill, Ontario • CANADA
FEI Number
3003272769
Location
Richmond Hill, Ontario
Country
CANADAAddress
25b East Pearce St, , Richmond Hill, Ontario, Canada
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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 |
|---|---|---|---|
| 11/29/2013 | 73CAXFLOWMETER, TUBE, THROPE, BACK-PRESSURE COMPENSATED | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 80KDPREGULATOR, VACUUM | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 80KDQBOTTLE, COLLECTION, VACUUM | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 73BYXTUBING, PRESSURE AND ACCESSORIES | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 80KDPREGULATOR, VACUUM | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 80KDQBOTTLE, COLLECTION, VACUUM | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 11/29/2013 | 73BYXTUBING, PRESSURE AND ACCESSORIES | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
| 3/19/2013 | 80KDPREGULATOR, VACUUM | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 3/19/2013 | 80KDPREGULATOR, VACUUM | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 3/19/2013 | 80KDPREGULATOR, VACUUM | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 8/15/2012 | 73CAXFLOWMETER, TUBE, THROPE, BACK-PRESSURE COMPENSATED | 341REGISTERED | Detroit District Office (DET-DO) |
| 4/8/2009 | 73CAXFLOWMETER, TUBE, THROPE, BACK-PRESSURE COMPENSATED | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Amvex Corporation's FDA import refusal history?
Amvex Corporation (FEI: 3003272769) has 12 FDA import refusal record(s) in our database, spanning from 4/8/2009 to 11/29/2013.
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. Amvex Corporation's FEI number is 3003272769.
What types of violations has Amvex Corporation received?
Amvex Corporation 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 Amvex Corporation come from?
All FDA import refusal data for Amvex Corporation 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.