Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-21.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Mar 2025 – 21 Mar 2025 | Human Drugs | 483 | View 483 → |
| 14 Oct 2019 – 18 Oct 2019 | Human Drugs | 483 | On file |
| 3 Apr 2018 – 6 Apr 2018 | Human Drugs | 483 | On file |
| 11 Sep 2017 – 15 Sep 2017 | Human Drugs | Clean | |
| 21 Sep 2015 – 25 Sep 2015 | Human Drugs | Clean | |
| 29 Jul 2013 – 2 Aug 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Brandy N Lepage1 insp.
Santiago Gallardo Johnson1 insp.
Tajah L Blackburn1 insp.
Seneca D Toms1 insp.
Mary-Jeanet Mcgarry1 insp.
Yumi J Hiramine1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Mayne Pharma International Pty Ltd.'s 4 Form 483s
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat