APOTEX INC
⚠️ Moderate Risk
FEI: 3012378179 • North York, Ontario • CANADA
FEI Number
3012378179
Location
North York, Ontario
Country
CANADAAddress
200 Barmac Dr, , 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
708LISTING
It has been determined the drug is not included in a list required by Section 510(j).
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
Frequently Asked Questions
What is APOTEX INC's FDA import refusal history?
APOTEX INC (FEI: 3012378179) has 2 FDA import refusal record(s) in our database, spanning from 3/23/2021 to 11/24/2023.
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 3012378179.
What types of violations has APOTEX INC received?
APOTEX INC has been cited for 2 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.