Overview
- 8 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-26.
At a glance
Inspections
8
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jan 2024 – 26 Jan 2024 | Biologics | 483 | View 483 → |
| 20 May 2019 – 6 Jun 2019 | Biologics | 483 | View 483 → |
| 15 May 2017 – 29 May 2017 | Biologics | 483 | On file |
| 8 Jun 2015 – 26 Jun 2015 | Biologics | 483 | On file |
| 10 Jun 2013 – 18 Jun 2013 | Biologics | 483 | On file |
| 24 Jun 2011 | Not recorded | 483 | On file |
| 27 Feb 2009 | Not recorded | 483 | On file |
| 11 Feb 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jan 2024
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Travis S Bradley, Roger F Zabinski
26 Jan 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Travis S Bradley, Roger F Zabinski
26 Jan 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Travis S Bradley, Roger F Zabinski
26 Jan 2024
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Travis S Bradley, Roger F Zabinski
26 Jan 2024
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Travis S Bradley, Roger F Zabinski
Investigators
FDA investigators tied to this site in the record.
Susan M Jackson3 insp.
Cynthia Jim2 insp.
Travis S Bradley1 insp.
Roger F Zabinski1 insp.
Omotunde O Osunsanmi1 insp.
Darla J Christopher1 insp.
John F Cipollo1 insp.
Debra M Emerson1 insp.
Jacqueline M Diaz Albert1 insp.
Paula A Trost1 insp.
Nicole K Trudel1 insp.
Joseph George1 insp.
Sean R Byrd1 insp.
Joseph D Doleski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | 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 |
| 21 CFR 211.67(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 211.89 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | 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 GlaxoSmithKline Vaccines Srl's 8 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