Apotex Inc.
⚠️ Moderate Risk
FEI: 3005072567 • Toronto, Ontario • CANADA
FEI Number
3005072567
Location
Toronto, Ontario
Country
CANADAAddress
200 Bonmac Dr, , Toronto, 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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/19/2012 | 63ECA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/27/2011 | 61ECK04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/4/2009 | 61TCY99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 2/24/2009 | 61VCA99ANTI-FLATULENT N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 2/19/2009 | 61CCB99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 10/9/2008 | 60SCP22FAMOTIDINE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/9/2008 | 66MCP03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/9/2008 | 62OCP13VERAPAMIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/7/2007 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/28/2005 | 65VDA15DIAZEPAM (SEDATIVE) | 473LABELING | Florida District Office (FLA-DO) |
| 4/8/2004 | 61WDY45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Apotex Inc.'s FDA import refusal history?
Apotex Inc. (FEI: 3005072567) has 11 FDA import refusal record(s) in our database, spanning from 4/8/2004 to 6/19/2012.
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. Apotex Inc.'s FEI number is 3005072567.
What types of violations has Apotex Inc. received?
Apotex Inc. 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 Apotex Inc. come from?
All FDA import refusal data for Apotex 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.