Company
IndiaMylan Laboratories Limited, Hosur, India – FDA Inspections
Inspection records and compliance data for Mylan Laboratories Limited in Hosur. 7 FDA inspections on record, 2 Form 483s, last inspected October 22, 2024.
Company Profile
This profile covers Mylan Laboratories Limited based in Hosur, India.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Unclassified
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected March 10, 2010. Last inspected October 22, 2024.
Most cited issue areas
- Environmental Monitoring System3 inspections
- Cleaning System2 inspections
- Scientifically sound laboratory controls2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 22, 2024 | Not classified | Human Drugs | 1255516 |
| May 17, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1237801 |
| September 17, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1152889 |
| May 24, 2019 | Not classified | Human Drugs · Drug Quality Assurance | 1092165 |
| May 15, 2017 | Not classified | Human Drugs · New Drug Evaluation | 1016064 |
| September 13, 2013 | VAI | Human Drugs · Drug Quality Assurance | 852088 |
| March 10, 2010 | VAI | Human Drugs · Drug Quality Assurance | 659111 |
FDA documents
People (5)
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Company Information
Name
Mylan Laboratories Limited
FEI Number
3008255419
Address
Plot No 14, Sipcot Ii; Krishnagiri Main Road, Hosur, India
Country
India
ID: 519a99b3-febc-4352-9486-0e1b63614973