Overview
- 14 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-30.
At a glance
Inspections
14
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2025 – 30 Jan 2025 | Human Drugs | 483 | On file |
| 13 Jun 2022 – 17 Jun 2022 | Human Drugs | Clean | |
| 9 Dec 2019 – 17 Dec 2019 | Biologics | 483 | On file |
| 21 Oct 2019 – 25 Oct 2019 | Human Drugs | 483 | On file |
| 8 Dec 2016 – 16 Dec 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jun 2015 – 3 Jul 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Jul 2013 – 11 Jul 2013 | Human Drugs | Clean | |
| 17 May 2011 | Not recorded | Clean | |
| 10 Jul 2009 | Not recorded | 483 | On file |
| 18 Dec 2008 | Not recorded | Clean | |
| 17 Sep 2004 | Not recorded | Clean | |
| 11 Mar 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Thuy T Nguyen1 insp.
Kejun Cheng1 insp.
Jie He1 insp.
MRA McCulloughJ1 insp.
Wayne E Seifert1 insp.
Rumany C Penn1 insp.
Marcus F Yambot1 insp.
Margaret M Annes1 insp.
Philip F Istafanos1 insp.
Marie F Morin1 insp.
Carla A Norris1 insp.
Rebecca Rodriguez1 insp.
Gwyn G Dickinson1 insp.
Temar Q Williams1 insp.
Mark R Mcclain1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Allergan Pharmaceuticals Ireland's 6 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