Mylan Pharmaceuticals ULC
⚠️ High Risk
FEI: 3002807060 • Etobicoke, Ontario • CANADA
FEI Number
3002807060
Location
Etobicoke, Ontario
Country
CANADAAddress
85 Advance Rd, , Etobicoke, 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).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/10/2025 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/11/2022 | 54ADK13VITAMIN C (ASCORBIC ACID) | Division of Southeast Imports (DSEI) | |
| 8/19/2021 | 66SCY28NITROGLYCERIN (TAB) (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2020 | 66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2020 | 80PQXEPINEPHRINE SYRINGE | Division of Northern Border Imports (DNBI) | |
| 11/26/2019 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/26/2019 | 61NCA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/4/2017 | 62OCE11TRANDOLAPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2015 | 66VAP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/7/2012 | 61NCY76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 61PDB55METFORMIN HCL (ANTI-DIABETIC) | 82RX LEGEND | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 61JDB14SIMVASTATIN (ANTI-CHOLESTEREMIC) | New Orleans District Office (NOL-DO) | |
| 12/13/2011 | 61FDB54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 12/13/2011 | 61LCA12WARFARIN POTASSIUM (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mylan Pharmaceuticals ULC's FDA import refusal history?
Mylan Pharmaceuticals ULC (FEI: 3002807060) has 14 FDA import refusal record(s) in our database, spanning from 12/13/2011 to 1/10/2025.
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. Mylan Pharmaceuticals ULC's FEI number is 3002807060.
What types of violations has Mylan Pharmaceuticals ULC received?
Mylan Pharmaceuticals ULC has been cited for 5 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 Mylan Pharmaceuticals ULC come from?
All FDA import refusal data for Mylan Pharmaceuticals ULC 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.