Company
AustraliaMayne Pharma International PTY LTD - Inspection Records
Inspection records and compliance data for Mayne Pharma International PTY LTD in Salisbury South. 6 FDA inspections on record, 1 Form 483, last inspected March 21, 2025.
Company Profile
This profile covers Mayne Pharma International PTY LTD based in Salisbury South, Australia.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 15, 2009. Last inspected March 21, 2025.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Procedures not in writing, fully followed1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 21, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1257835 |
| October 18, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1110711 |
| September 15, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1035729 |
| September 25, 2015 | VAI | Human Drugs · Drug Quality Assurance | 945811 |
| August 2, 2013 | VAI | Human Drugs · Drug Quality Assurance | 846520 |
| May 15, 2009 | VAI | Human Drugs · Drug Quality Assurance | 588986 |
FDA documents
Form 483s (1)
Company Information
Name
Mayne Pharma International PTY LTD
FEI Number
3004090027
Address
1538 Main North Rd, Salisbury South, Australia
Country
Australia
ID: 073fd71d-43f6-4a53-9597-0951e7459d08