Auro Pharma Inc.
⚠️ High Risk
FEI: 3012241046 • Woodbridge, Ontario • CANADA
FEI Number
3012241046
Location
Woodbridge, Ontario
Country
CANADAAddress
402-3700 Steeles Ave W, , Woodbridge, 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
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 |
|---|---|---|---|
| 12/9/2025 | 66SCY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2025 | 61PCA70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 66SCA51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2024 | 61FCA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2023 | 66SCA51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2022 | 61NCA74MODAFINIL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Auro Pharma Inc.'s FDA import refusal history?
Auro Pharma Inc. (FEI: 3012241046) has 7 FDA import refusal record(s) in our database, spanning from 9/20/2022 to 12/9/2025.
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. Auro Pharma Inc.'s FEI number is 3012241046.
What types of violations has Auro Pharma Inc. received?
Auro Pharma Inc. 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 Auro Pharma Inc. come from?
All FDA import refusal data for Auro Pharma 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.