Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-25.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Sep 2024 – 25 Sep 2024 | Human Drugs | Clean | |
| 31 Jul 2023 – 8 Aug 2023 | Human Drugs | 483 | View 483 → |
| 29 Mar 2021 – 6 Apr 2021 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Aug 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Marcus F Yambot, Heidy C Perales
8 Aug 2023
21 CFR 211.84(e)
Rejecting When Specifications Not Met
Cited by Marcus F Yambot, Heidy C Perales
8 Aug 2023
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Marcus F Yambot, Heidy C Perales
8 Aug 2023
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Marcus F Yambot, Heidy C Perales
Investigators
FDA investigators tied to this site in the record.
Tanya R Syffrard1 insp.
Marcus F Yambot1 insp.
Heidy C Perales1 insp.
Yasamin Ameri1 insp.
Atul Agrawal1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cyclomedica Australia Pty Limited's 2 Form 483s
Source PDFs 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