Overview
- 16 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-20.
At a glance
Inspections
16
Form 483s
10
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 20 Jan 2026 | Biologics | WL | On file |
| 9 Jan 2025 – 17 Jan 2025 | Human Drugs | 483 | On file |
| 21 Feb 2022 – 25 Feb 2022 | Human Drugs | Clean | |
| 28 Nov 2018 – 5 Dec 2018 | Human Drugs | Clean | |
| 12 Feb 2018 – 16 Feb 2018 | Biologics | Clean | |
| 8 Jun 2017 – 16 Jun 2017 | Human Drugs | 483 | View 483 → |
| 24 Aug 2015 – 2 Sep 2015 | Human Drugs | 483 | On file |
| 24 Feb 2014 – 27 Feb 2014 | Human Drugs | 483 | On file |
| 18 Sep 2013 – 26 Sep 2013 | Biologics | 483 | On file |
| 22 Jul 2013 – 30 Jul 2013 | Human Drugs | 483 | On file |
| 10 Feb 2012 | Not recorded | Clean | |
| 30 Sep 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jun 2017
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Scott T Ballard, Wayne E Seifert
16 Jun 2017
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Scott T Ballard, Wayne E Seifert
Investigators
FDA investigators tied to this site in the record.
Wayne E Seifert2 insp.
Omotunde O Osunsanmi2 insp.
Massoud Motamed1 insp.
Jogy George1 insp.
Andrea Franco1 insp.
MRA MunizN1 insp.
Zhihao Pete Qiu1 insp.
Jacqueline M Diaz Albert1 insp.
Burnell M Henry1 insp.
Scott T Ballard1 insp.
Simone E Pitts1 insp.
Michael R Goga1 insp.
Cynthia Jim1 insp.
Helen B Ricalde1 insp.
Margaret M Annes1 insp.
Robert M Barbosa1 insp.
Kalavati C Suvarna1 insp.
Susan M Jackson1 insp.
Paula A Trost1 insp.
Douglas A Campbell1 insp.
Jose R Hernandez1 insp.
Rose M Ashley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Genzyme Ireland Limited's 10 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