Mylan Laboratories Limited
⚠️ High Risk
FEI: 3005587313 • Nashik, Maharashtra • INDIA
FEI Number
3005587313
Location
Nashik, Maharashtra
Country
INDIAAddress
(FDF-1), F-4 and F-12, Malegaon MIDC, Sinnar, , Nasik, Nashik, Maharashtra, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2023 | 62VDA15TENOFOVIR DISOPROXIL FUMERATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2022 | 62OCB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | Division of Northeast Imports (DNEI) | |
| 4/29/2022 | 62OCB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | Division of Northeast Imports (DNEI) | |
| 4/29/2022 | 62OCB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | Division of Northeast Imports (DNEI) | |
| 12/7/2018 | 62VDY78LAMIVUDINE; ZIDOVUDINE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2018 | 62VCB15TENOFOVIR DISOPROXIL FUMERATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2017 | 62VCA15TENOFOVIR DISOPROXIL FUMERATE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/12/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/9/2011 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 12/9/2011 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 12/9/2011 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 12/9/2011 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 12/9/2011 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 12/9/2011 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 12/9/2011 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 12/9/2011 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 12/9/2011 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Mylan Laboratories Limited's FDA import refusal history?
Mylan Laboratories Limited (FEI: 3005587313) has 17 FDA import refusal record(s) in our database, spanning from 12/9/2011 to 1/3/2023.
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 3005587313.
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.