Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-28.
At a glance
Inspections
10
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jun 2024 – 28 Jun 2024 | Human Drugs | 483 | View 483 → |
| 29 Apr 2024 – 3 May 2024 | Human Drugs | Clean | |
| 21 Oct 2019 – 24 Oct 2019 | Human Drugs | Clean | |
| 11 Sep 2017 – 15 Sep 2017 | Human Drugs | Clean | |
| 29 Jun 2015 – 2 Jul 2015 | Human Drugs | Clean | |
| 15 Jul 2013 – 18 Jul 2013 | Human Drugs | 483 | On file |
| 17 Jun 2011 | Not recorded | 483 | View 483 → |
| 30 Oct 2008 | Not recorded | 483 | On file |
| 6 Apr 2000 | Not recorded | Clean | |
| 20 Oct 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jun 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Nancy G Schmidt, Marianela Aponte Cruz
17 Jun 2011
21 CFR 211.80(b)
Handling and Storage to Prevent Contamination
Cited by Nancy G Schmidt, Marianela Aponte Cruz
Investigators
FDA investigators tied to this site in the record.
Anastasia M Shields1 insp.
Ruben C Ayala1 insp.
Li-Hong P Yeh1 insp.
Santiago Gallardo Johnson1 insp.
Lucas B Leake1 insp.
Nicholas A Violand1 insp.
Yumi J Hiramine1 insp.
Nancy G Schmidt1 insp.
Marianela Aponte Cruz1 insp.
Michael A Charles1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alphapharm Pty Ltd's 4 Form 483s
Source PDFs, verbatim observations, and 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