Apotex Corp.
⚠️ High Risk
FEI: 3006727872 • Weston, FL • UNITED STATES
FEI Number
3006727872
Location
Weston, FL
Country
UNITED STATESAddress
2400 N Commerce Pkwy Ste 400, , Weston, FL, United States
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2025 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/8/2020 | 61NDY86ESKETAMINE HYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 61JDA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2019 | 64BCA27ISOSORBIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2019 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2009 | 56CDK70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 179AGR RX | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Apotex Corp.'s FDA import refusal history?
Apotex Corp. (FEI: 3006727872) has 6 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 7/24/2025.
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 Corp.'s FEI number is 3006727872.
What types of violations has Apotex Corp. received?
Apotex Corp. 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 Corp. come from?
All FDA import refusal data for Apotex Corp. 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.