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, None, 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
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| October 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Documents (7)
FDA Inspection 1257835 - Mayne Pharma International PTY LTD - 2025-03-21
fda_inspection
483 - Mayne Pharma International PTY LTD - 2019-10-18
483
FDA Inspection 1110711 - Mayne Pharma International PTY LTD - 2019-10-18
fda_inspection
FDA Inspection 1035729 - Mayne Pharma International PTY LTD - 2017-09-15
fda_inspection
FDA Inspection 945811 - Mayne Pharma International PTY LTD - 2015-09-25
fda_inspection
FDA Inspection 846520 - Mayne Pharma International PTY LTD - 2013-08-02
fda_inspection
FDA Inspection 588986 - Mayne Pharma International PTY LTD - 2009-05-15
fda_inspection
Related Companies
Companies with similar regulatory profiles, compliance history, and operations.
No related companies are listed in the preview. Use search below to find similar companies or view the full directory for this location.
Search nearby companiesCompany Information
Name
Mayne Pharma International PTY LTD
FEI Number
3004090027
State
None
City
Salisbury South
ID: 073fd71d-43f6-4a53-9597-0951e7459d08