Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-26.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jan 2024 – 26 Jan 2024 | Biologics | Clean | |
| 3 Jun 2019 – 6 Jun 2019 | Biologics | 483 | View 483 → |
| 24 May 2017 – 29 May 2017 | Biologics | 483 | On file |
| 23 Jun 2015 – 26 Jun 2015 | Biologics | 483 | On file |
| 13 Jun 2011 | Not recorded | 483 | On file |
| 18 Jun 2010 | Not recorded | 483 | On file |
| 13 Feb 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Jun 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Omotunde O Osunsanmi, Darla J Christopher
6 Jun 2019
21 CFR 211.67(b)(2)
Cleaning SOPs/schedules
Cited by Omotunde O Osunsanmi, Darla J Christopher
Investigators
FDA investigators tied to this site in the record.
Susan M Jackson2 insp.
Travis S Bradley1 insp.
Roger F Zabinski1 insp.
Omotunde O Osunsanmi1 insp.
Darla J Christopher1 insp.
Cynthia Jim1 insp.
Debra M Emerson1 insp.
Jacqueline M Diaz Albert1 insp.
Paula A Trost1 insp.
Helen B Ricalde1 insp.
Rebecca K Olin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.18(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GSK Vaccines S.r.l.'s 6 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