Apotex, Inc.
⚠️ High Risk
FEI: 3002808376 • Etobicoke, Ontario • CANADA
FEI Number
3002808376
Location
Etobicoke, Ontario
Country
CANADAAddress
50 Steinway Blvd, , Etobicoke, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
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 |
|---|---|---|---|
| 3/24/2020 | 61NDY78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2019 | 62ODA42METIPRANOLOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2018 | 60SIB25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Southeast Imports (DSEI) | |
| 8/16/2012 | 63ACA02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | New Orleans District Office (NOL-DO) | |
| 9/28/2009 | 61NCE37LITHIUM CARBONATE (ANTI-DEPRESSANT) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 66NCA07OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61FCA56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCA34FOSINOPRIL SODIUM (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62KCF10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61MCA38LAMOTRIGINE (ANTI-CONVULSANT) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61NCA73MIRTAZAPINE (ANTI-DEPRESSANT) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61NCA69GABAPENTIN (ANTI-DEPRESSANT) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62CDA65LISINOPRIL (ANTI-HYPERTENSIVE) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCF24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 64BDA40TRIAMTERENE (DIURETIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCF24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62CCA65LISINOPRIL (ANTI-HYPERTENSIVE) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCA27DOXAZOSIN MESYLATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCF24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCF24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61NCE69GABAPENTIN (ANTI-DEPRESSANT) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCA27DOXAZOSIN MESYLATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCA27DOXAZOSIN MESYLATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62CCA65LISINOPRIL (ANTI-HYPERTENSIVE) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62CCA65LISINOPRIL (ANTI-HYPERTENSIVE) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 66NCA07OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62KCF10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61FCA56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 66TCA01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61NCE37LITHIUM CARBONATE (ANTI-DEPRESSANT) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62YCE05BALSALAZIDE DISODIUM (ANTI-INFLAMMATORY, PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61MCA38LAMOTRIGINE (ANTI-CONVULSANT) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCA27DOXAZOSIN MESYLATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCF24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 61NCA05BUPROPION HCL (ANTI-DEPRESSANT) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCE10TERAZOSIN HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62OCF24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/28/2009 | 62KCF10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 5/6/2008 | 65VCB15DIAZEPAM (SEDATIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/12/2006 | 62CAL41MINOXIDIL (ANTI-HYPERTENSIVE) | New York District Office (NYK-DO) | |
| 12/10/2005 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/2/2005 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Apotex, Inc.'s FDA import refusal history?
Apotex, Inc. (FEI: 3002808376) has 54 FDA import refusal record(s) in our database, spanning from 11/2/2005 to 3/24/2020.
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 3002808376.
What types of violations has Apotex, Inc. received?
Apotex, Inc. 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 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.