Company
IndiaMylan Laboratories Limited (FDF-2), Aurangabad, India – FDA Inspections
Inspection records and compliance data for Mylan Laboratories Limited (FDF-2) in Aurangabad. 6 FDA inspections on record, 1 Form 483, last inspected February 03, 2023.
Company Profile
This profile covers Mylan Laboratories Limited (FDF-2) based in Aurangabad, India.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 9, 2012. Last inspected February 3, 2023.
Most cited issue areas
- Computer control of master formula records1 inspection
- Failure to meet specifications1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 3, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1253435 |
| February 28, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1122884 |
| April 26, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1091217 |
| May 26, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1012796 |
| May 16, 2014 | NAI | Human Drugs · Drug Quality Assurance | 884211 |
| March 9, 2012 | VAI | Human Drugs · Drug Quality Assurance | 775616 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Mylan Laboratories Limited (FDF-2)
FEI Number
3008316970
Address
H-12 & H-13 Midc, Waluj, Aurangabad, India
Country
India
ID: 1bcb64f5-f3f2-412e-81da-b3efab26f310