Eco-Med Pharmaceuticals, Inc.
⚠️ Moderate Risk
FEI: 3014745648 • Etobicoke, Ontario • CANADA
FEI Number
3014745648
Location
Etobicoke, Ontario
Country
CANADAAddress
151 Carlingview Dr Unit 14, , Etobicoke, 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
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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).
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 |
|---|---|---|---|
| 12/6/2021 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 2800POSS N/STR | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 2800POSS N/STR | Division of Northern Border Imports (DNBI) |
| 12/6/2021 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 2800POSS N/STR | Division of Northern Border Imports (DNBI) |
| 11/12/2021 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 78STERILITY | Division of Northern Border Imports (DNBI) |
| 11/12/2021 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 78STERILITY | Division of Northern Border Imports (DNBI) |
| 12/11/2007 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/22/2003 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Eco-Med Pharmaceuticals, Inc.'s FDA import refusal history?
Eco-Med Pharmaceuticals, Inc. (FEI: 3014745648) has 7 FDA import refusal record(s) in our database, spanning from 12/22/2003 to 12/6/2021.
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. Eco-Med Pharmaceuticals, Inc.'s FEI number is 3014745648.
What types of violations has Eco-Med Pharmaceuticals, Inc. received?
Eco-Med Pharmaceuticals, Inc. 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 Eco-Med Pharmaceuticals, Inc. come from?
All FDA import refusal data for Eco-Med Pharmaceuticals, Inc. 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.