Mylan Laboratories Limited
⚠️ High Risk
FEI: 3010453141 • District Dhar, Madhya Pradesh • INDIA
FEI Number
3010453141
Location
District Dhar, Madhya Pradesh
Country
INDIAAddress
(FDF-3) Plot Nos. 11, 12, 13, Indore SEZ, Pharma Zone, Phase II, Sector III, Pithampur, District Dhar, Madhya Pradesh, 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).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/8/2025 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 331DR QUALITC | Division of Southeast Imports (DSEI) |
| 3/13/2025 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 331DR QUALITC | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 62VCY15TENOFOVIR DISOPROXIL FUMERATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2024 | 62VDA99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2023 | 62VDY73DOLUTEGRAVIR SODIUM (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/25/2022 | 62VDY77EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2021 | 62VDB15TENOFOVIR DISOPROXIL FUMERATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Mylan Laboratories Limited's FDA import refusal history?
Mylan Laboratories Limited (FEI: 3010453141) has 7 FDA import refusal record(s) in our database, spanning from 9/15/2021 to 4/8/2025.
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 Limited's FEI number is 3010453141.
What types of violations has Mylan Laboratories Limited received?
Mylan Laboratories Limited 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 Limited come from?
All FDA import refusal data for Mylan Laboratories Limited 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.