Toronto Research Chemicals
⚠️ Moderate Risk
FEI: 1000543247 • North York, Ontario • CANADA
FEI Number
1000543247
Location
North York, Ontario
Country
CANADAAddress
2 Brisbane Rd, , North York, 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
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).
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.
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 |
|---|---|---|---|
| 8/8/2017 | 75OTVRESEARCH USE ONLY/CLINICAL CHEMISTRY DEVICES | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 2/19/2016 | 56BYY51PENICILLAMINE (PENICILLIN, SYNTHETICALLY PRODUCED) | Cincinnati District Office (CIN-DO) | |
| 8/23/2011 | 61NIY80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/24/2011 | 88LDTREAGENT, GENERAL PURPOSE | New Orleans District Office (NOL-DO) | |
| 6/10/2011 | 66NIZ02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/10/2011 | 65VIZ13CLOZAPINE (SEDATIVE) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/5/2011 | 61LIY13WARFARIN SODIUM (ANTI-COAGULANT) | New Orleans District Office (NOL-DO) | |
| 3/9/2006 | 66QCZ03PROBENECID (URICOSURIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 10/21/2005 | 62GDY89CYCLOSPORINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/21/2005 | 62GDY89CYCLOSPORINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 65QIY65TIZANIDINE HCL (RELAXANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 12/13/2004 | 62VCZ20AMPRENAVIR (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/9/2004 | 61NCY12COTININE FUMARATE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Toronto Research Chemicals's FDA import refusal history?
Toronto Research Chemicals (FEI: 1000543247) has 13 FDA import refusal record(s) in our database, spanning from 12/9/2004 to 8/8/2017.
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. Toronto Research Chemicals's FEI number is 1000543247.
What types of violations has Toronto Research Chemicals received?
Toronto Research Chemicals 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 Toronto Research Chemicals come from?
All FDA import refusal data for Toronto Research Chemicals 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.