Trexo Robotics Holdings Inc.
⚠️ High Risk
FEI: 3015275209 • Mississauga, Ontario • CANADA
FEI Number
3015275209
Location
Mississauga, Ontario
Country
CANADAAddress
6705 Millcreek Dr Unit 3, , Mississauga, Ontario, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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.
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).
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 |
|---|---|---|---|
| 4/17/2025 | 89IKKSYSTEM, ISOKINETIC TESTING AND EVALUATION | Division of Northern Border Imports (DNBI) | |
| 4/17/2025 | 89IKKSYSTEM, ISOKINETIC TESTING AND EVALUATION | Division of Northern Border Imports (DNBI) | |
| 2/20/2025 | 89KNOACCESSORIES, WHEELCHAIR | Division of Northern Border Imports (DNBI) | |
| 1/24/2025 | 89IKKSYSTEM, ISOKINETIC TESTING AND EVALUATION | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 12/23/2024 | 89IKKSYSTEM, ISOKINETIC TESTING AND EVALUATION | Division of Southeast Imports (DSEI) | |
| 10/8/2024 | 89IKKSYSTEM, ISOKINETIC TESTING AND EVALUATION | Division of Southeast Imports (DSEI) | |
| 10/2/2024 | 89IKKSYSTEM, ISOKINETIC TESTING AND EVALUATION | Division of Southeast Imports (DSEI) | |
| 9/17/2024 | 89IKKSYSTEM, ISOKINETIC TESTING AND EVALUATION | Division of Southeast Imports (DSEI) | |
| 9/5/2024 | 89IKKSYSTEM, ISOKINETIC TESTING AND EVALUATION | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Trexo Robotics Holdings Inc.'s FDA import refusal history?
Trexo Robotics Holdings Inc. (FEI: 3015275209) has 9 FDA import refusal record(s) in our database, spanning from 9/5/2024 to 4/17/2025.
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. Trexo Robotics Holdings Inc.'s FEI number is 3015275209.
What types of violations has Trexo Robotics Holdings Inc. received?
Trexo Robotics Holdings Inc. has been cited for 5 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 Trexo Robotics Holdings Inc. come from?
All FDA import refusal data for Trexo Robotics Holdings 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.