The Exchange Tower
⚠️ High Risk
FEI: 3011712078 • Toronto, Ontario • CANADA
FEI Number
3011712078
Location
Toronto, Ontario
Country
CANADAAddress
130 King St W, , Toronto, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
AGRINSULIN
The article appears to be composed wholly or partly of insulin manufactured in the US and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for a medical emergency
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/24/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCY58INSULIN LISPRO PROTAMINE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/21/2025 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/21/2025 | 61PDL17INSULIN (INJ) (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/21/2025 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2025 | 61PCY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/31/2024 | 61PCP99ANTI-DIABETIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/22/2024 | 61PCK74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is The Exchange Tower's FDA import refusal history?
The Exchange Tower (FEI: 3011712078) has 8 FDA import refusal record(s) in our database, spanning from 11/22/2024 to 1/24/2025.
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. The Exchange Tower's FEI number is 3011712078.
What types of violations has The Exchange Tower received?
The Exchange Tower has been cited for 3 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 The Exchange Tower come from?
All FDA import refusal data for The Exchange Tower 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.