Mylan Pharmaceuticals Inc
⚠️ Moderate Risk
FEI: 1110315 • Morgantown, WV • UNITED STATES
FEI Number
1110315
Location
Morgantown, WV
Country
UNITED STATESAddress
3711 Collins Ferry Rd, , Morgantown, WV, United States
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).
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 |
|---|---|---|---|
| 8/14/2020 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/26/2016 | 62OCY22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 9/29/2011 | 66VIF99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/8/2011 | 64XCB11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/27/2007 | 60LCB69TRAMADOL HCL (ANALGESIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mylan Pharmaceuticals Inc's FDA import refusal history?
Mylan Pharmaceuticals Inc (FEI: 1110315) has 5 FDA import refusal record(s) in our database, spanning from 3/27/2007 to 8/14/2020.
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 Inc's FEI number is 1110315.
What types of violations has Mylan Pharmaceuticals Inc received?
Mylan Pharmaceuticals 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 Mylan Pharmaceuticals Inc come from?
All FDA import refusal data for Mylan Pharmaceuticals 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.