Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-04.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 May 2024 – 4 Jun 2024 | Biologics | Clean | |
| 4 Mar 2024 – 12 Mar 2024 | Biologics | 483 | View 483 → |
| 5 Sep 2022 – 13 Sep 2022 | Biologics | 483 | View 483 → |
| 7 Nov 2018 – 13 Nov 2018 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Mar 2024
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Susan M Jackson, Latorie S Jones
12 Mar 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Susan M Jackson, Latorie S Jones
Investigators
FDA investigators tied to this site in the record.
Viviana R Ramirez1 insp.
Susan M Jackson1 insp.
Latorie S Jones1 insp.
Gene D Arcy1 insp.
Lewis K Antwi1 insp.
Randa Melhem1 insp.
Lily Y Koo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GlaxoSmithKline Biologicals' 3 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