Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-06.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Dec 2024 – 6 Dec 2024 | Human Drugs | Clean | |
| 31 Oct 2022 – 4 Nov 2022 | Human Drugs | Clean | |
| 2 Sep 2019 – 6 Sep 2019 | Human Drugs | 483 | View 483 → |
| 21 Jan 2019 – 25 Jan 2019 | Human Drugs | Clean | |
| 6 Jul 2015 – 10 Jul 2015 | Human Drugs | Clean | |
| 8 Sep 2014 – 12 Sep 2014 | Human Drugs | Clean | |
| 17 Apr 2013 – 25 Apr 2013 | Human Drugs | 483 | View 483 → |
| 30 Mar 2012 | Not recorded | 483 | View 483 → |
| 21 Jul 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Apr 2013
21 CFR 211.65(a)
Equipment construction - reactive surfaces
Cited by Russell J Glapion, Linda L Ng, Richard L Rutherford, Xiaobin Shen
25 Apr 2013
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Russell J Glapion, Linda L Ng, Richard L Rutherford, Xiaobin Shen
25 Apr 2013
21 CFR 211.111
Deviations of production time limits
Cited by Russell J Glapion, Linda L Ng, Richard L Rutherford, Xiaobin Shen
30 Mar 2012
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael E Maselli, Charisse K Green
Investigators
FDA investigators tied to this site in the record.
MRA V MillarW1 insp.
Ileana Barreto-Pettit1 insp.
Sharmista Chatterjee1 insp.
Colleen F Hoyt1 insp.
Feiyan Jin1 insp.
Erika V Butler1 insp.
MRA DavisM1 insp.
Patrice S Hall1 insp.
Steven D Kehoe1 insp.
Russell J Glapion1 insp.
Linda L Ng1 insp.
Richard L Rutherford1 insp.
Xiaobin Shen1 insp.
Michael E Maselli1 insp.
Charisse K Green1 insp.
Rebecca Rodriguez1 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 | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Glaxo Operations UK Ltd's 3 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