Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-19.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Dec 2025 – 19 Dec 2025 | Biologics | 483 | View 483 → |
| 5 Feb 2020 – 7 Feb 2020 | Human Drugs | Clean | |
| 15 Jul 2019 – 19 Jul 2019 | Human Drugs | Clean | |
| 22 Oct 2018 – 25 Oct 2018 | Human Drugs | Clean | |
| 20 Jun 2016 – 22 Jun 2016 | Human Drugs | Clean | |
| 9 Nov 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Dec 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Peng Zhou, Thai D Truong
9 Nov 2011
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Kim L Thomas Cruse, Matthew R Dionne
9 Nov 2011
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Kim L Thomas Cruse, Matthew R Dionne
9 Nov 2011
21 CFR 211.165(e)
Test methods
Cited by Kim L Thomas Cruse, Matthew R Dionne
Investigators
FDA investigators tied to this site in the record.
Peng Zhou1 insp.
Thai D Truong1 insp.
Adetutu M Gidado1 insp.
MRA McCulloughJ1 insp.
Truong X Nguyen1 insp.
Margaret M Annes1 insp.
Kim L Thomas Cruse1 insp.
Matthew R Dionne1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PPD Development Ireland Ltd.'s 2 Form 483s
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