Mylan Laboratories Inc
⚠️ Moderate Risk
FEI: 3005071114 • Canonsburg, PA • UNITED STATES
FEI Number
3005071114
Location
Canonsburg, PA
Country
UNITED STATESAddress
1500 Corporate Dr Ste 400, , Canonsburg, PA, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/21/2009 | 61KDB34OXYBUTYNIN CHLORIDE (ANTI-CHOLINERGIC) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 8/21/2009 | 62YDA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 8/21/2009 | 60XDA20NADOLOL (ANTI-ADRENERGIC) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 8/12/2005 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Mylan Laboratories Inc's FDA import refusal history?
Mylan Laboratories Inc (FEI: 3005071114) has 4 FDA import refusal record(s) in our database, spanning from 8/12/2005 to 8/21/2009.
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 Laboratories Inc's FEI number is 3005071114.
What types of violations has Mylan Laboratories Inc received?
Mylan Laboratories 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 Mylan Laboratories Inc come from?
All FDA import refusal data for Mylan Laboratories 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.