Company
IndiaMylan Laboratories Limited, Sinnar, Nashik, India – FDA Inspections
Inspection records and compliance data for Mylan Laboratories Limited in Sinnar, Nashik. 9 FDA inspections on record (1 OAI), 3 Form 483s, last inspected May 24, 2024.
Company Profile
This profile covers Mylan Laboratories Limited based in Sinnar, Nashik, India.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 1
- VAI
- 4
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected August 8, 2009. Last inspected May 24, 2024.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance2 inspections
- Investigations of discrepancies, failures2 inspections
- Buildings not maintained in good state of repair1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 24, 2024 | Not classified | Human Drugs · Drug Quality Assurance | 1238860 |
| February 7, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1117137 |
| January 18, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1076887 |
| April 12, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1050962 |
| September 14, 2016 | OAI | Human Drugs · Drug Quality Assurance | 986244 |
| March 25, 2015 | VAI | Human Drugs · Drug Quality Assurance | 920472 |
| August 30, 2012 | NAI | Human Drugs · Drug Quality Assurance | 801056 |
| May 27, 2011 | VAI | Human Drugs · Drug Quality Assurance | 730088 |
| August 8, 2009 | NAI | Human Drugs · Drug Quality Assurance | 607779 |
FDA documents
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Company Information
Name
Mylan Laboratories Limited
FEI Number
3005587313
Address
(FDF-1), F-4 and F-12, Malegaon MIDC, Pune-Nashik Road, Sinnar, Nashik, India
Country
India
ID: 4fd10a2e-3696-4bd0-82aa-e875143028c0