Meditech International Inc.
⚠️ Moderate Risk
FEI: 3003082988 • Etobicoke, Ontario • CANADA
FEI Number
3003082988
Location
Etobicoke, Ontario
Country
CANADAAddress
411 Horner Ave, UNIT No. 1, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/2/2018 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 3/24/2016 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 3/24/2016 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 3/24/2016 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Meditech International Inc.'s FDA import refusal history?
Meditech International Inc. (FEI: 3003082988) has 4 FDA import refusal record(s) in our database, spanning from 3/24/2016 to 11/2/2018.
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. Meditech International Inc.'s FEI number is 3003082988.
What types of violations has Meditech International Inc. received?
Meditech International Inc. has been cited for 1 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 Meditech International Inc. come from?
All FDA import refusal data for Meditech International 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.