Overview
- 12 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-11.
At a glance
Inspections
12
Form 483s
10
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 May 2023 – 11 May 2023 | Human Drugs | 483 | On file |
| 16 Jan 2023 – 24 Jan 2023 | Biologics | Clean | |
| 4 Nov 2019 – 12 Nov 2019 | Biologics | 483 | View 483 → |
| 10 Sep 2018 – 18 Sep 2018 | Biologics | 483 | On file |
| 6 Mar 2017 – 10 Mar 2017 | Human Drugs | 483 | View 483 → |
| 12 Sep 2016 – 20 Sep 2016 | Biologics | 483 | On file |
| 9 Jun 2014 – 17 Jun 2014 | Biologics | 483 | On file |
| 7 Oct 2013 – 15 Oct 2013 | Human Drugs | Clean | |
| 28 Jun 2012 | Not recorded | 483 | On file |
| 31 Aug 2010 | Not recorded | 483 | On file |
| 19 Aug 2009 | Not recorded | 483 | On file |
| 24 Apr 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Mar 2017
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Bijoy Panicker, Patric C Klotzbuecher
Investigators
FDA investigators tied to this site in the record.
Mihaly S Ligmond3 insp.
Madushini N Dharmasena1 insp.
Susan M Jackson1 insp.
Scott E Norris1 insp.
Bijoy Panicker1 insp.
Patric C Klotzbuecher1 insp.
Prabhu P Raju1 insp.
Jacqueline M Diaz Albert1 insp.
Paula A Trost1 insp.
Linda Thai1 insp.
Omotunde O Osunsanmi1 insp.
Cynthia Jim1 insp.
Rose M Ashley1 insp.
Nancy T Waites1 insp.
Michele L Obert1 insp.
Alicia M Mozzachio1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pfizer Ireland Pharmaceuticals Unlimited Company's 10 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