Mylan Laboratories Ltd.
⚠️ High Risk
FEI: 3009400408 • Hyderabad, Telangana • INDIA
FEI Number
3009400408
Location
Hyderabad, Telangana
Country
INDIAAddress
Plot 564/A/22, Jubilee Hills, Road No. 92, Hyderabad, Telangana, India
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/2/2025 | 66JAA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/11/2019 | 62VDA77EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/13/2018 | 62OIS41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Mylan Laboratories Ltd.'s FDA import refusal history?
Mylan Laboratories Ltd. (FEI: 3009400408) has 3 FDA import refusal record(s) in our database, spanning from 4/13/2018 to 7/2/2025.
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 Laboratories Ltd.'s FEI number is 3009400408.
What types of violations has Mylan Laboratories Ltd. received?
Mylan Laboratories Ltd. 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 Laboratories Ltd. come from?
All FDA import refusal data for Mylan Laboratories Ltd. 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.