Overview
- 14 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-15.
At a glance
Inspections
14
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 May 2025 – 15 May 2025 | Human Drugs | 483 | On file |
| 16 Oct 2023 – 26 Oct 2023 | Human Drugs | Clean | |
| 8 Nov 2021 – 12 Nov 2021 | Human Drugs | 483 | On file |
| 17 Feb 2020 – 21 Feb 2020 | Human Drugs | Clean | |
| 25 Sep 2017 – 29 Sep 2017 | Human Drugs | Clean | |
| 11 Jul 2016 – 22 Jul 2016 | Human Drugs | Clean | |
| 19 May 2015 – 27 May 2015 | Human Drugs | 483 | View 483 → |
| 3 Jul 2013 – 10 Jul 2013 | Human Drugs | Clean | |
| 21 Sep 2012 | Not recorded | Clean | |
| 28 Jun 2011 | Not recorded | Clean | |
| 31 Jul 2008 | Not recorded | 483 | On file |
| 30 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
27 May 2015
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by April L Young
Investigators
FDA investigators tied to this site in the record.
Karina M Zuck1 insp.
Madushini N Dharmasena1 insp.
Sarah A Johnson1 insp.
Olumide A Martins1 insp.
MRA MunizN1 insp.
Michael Shanks1 insp.
Nayan J Patel1 insp.
Mark D Johnson1 insp.
MRA McCulloughJ1 insp.
Sangeeta M Khurana1 insp.
Junho Pak1 insp.
April L Young1 insp.
Paul C Mouris1 insp.
James D Bridges1 insp.
Salvatore N Randazzo1 insp.
Julie D Bringger1 insp.
Rose M Ashley1 insp.
Susan M Jackson1 insp.
Regina T Brown1 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 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GlaxoSmithKline Manufacturing S.p.A.'s 5 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