Apotex
⚠️ High Risk
FEI: 3011504392 • Macquarie Park • AUSTRALIA
FEI Number
3011504392
Location
Macquarie Park
Country
AUSTRALIAAddress
Level3, , Macquarie Park, , Australia
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2018 | 66NCY03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/28/2018 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/28/2018 | 63ECY13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/28/2018 | 62TCY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/28/2018 | 61NCY05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/28/2018 | 61MCY38LAMOTRIGINE (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Apotex's FDA import refusal history?
Apotex (FEI: 3011504392) has 6 FDA import refusal record(s) in our database, spanning from 2/28/2018 to 2/28/2018.
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's FEI number is 3011504392.
What types of violations has Apotex received?
Apotex has been cited for 1 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 come from?
All FDA import refusal data for Apotex 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.