Apotex Inc.
⚠️ Moderate Risk
FEI: 3001617666 • Richmond Hill, Ontario • CANADA
FEI Number
3001617666
Location
Richmond Hill, Ontario
Country
CANADAAddress
380 Elgin Mills Rd E, , Richmond Hill, 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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/10/2021 | 64LAA56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/13/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 2/27/2002 | 66VCP99MISCELLANEOUS 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: 3001617666) has 3 FDA import refusal record(s) in our database, spanning from 2/27/2002 to 3/10/2021.
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 3001617666.
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.