Mylan Specialty, L.P.
⚠️ Moderate Risk
FEI: 2938970 • Morgantown, WV • UNITED STATES
FEI Number
2938970
Location
Morgantown, WV
Country
UNITED STATESAddress
781 Chestnut Ridge Rd Fl 3, , 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
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.
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).
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 |
|---|---|---|---|
| 4/19/2011 | 60CIY04EPINEPHRINE (ADRENERGIC) | Detroit District Office (DET-DO) | |
| 10/13/2004 | 61EBY06FEXOFENADINE HCL (ANTI-ASTHMATIC) | Detroit District Office (DET-DO) | |
| 11/5/2003 | 60CCP04EPINEPHRINE (ADRENERGIC) | 179AGR RX | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Mylan Specialty, L.P.'s FDA import refusal history?
Mylan Specialty, L.P. (FEI: 2938970) has 3 FDA import refusal record(s) in our database, spanning from 11/5/2003 to 4/19/2011.
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 Specialty, L.P.'s FEI number is 2938970.
What types of violations has Mylan Specialty, L.P. received?
Mylan Specialty, L.P. has been cited for 4 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 Specialty, L.P. come from?
All FDA import refusal data for Mylan Specialty, L.P. 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.